N
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
MAUDE MDR 5229860
- MDR report key
- 5229860
- Report number
- 1063481-2015-00347
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-10-30
- Date received
- 2015-11-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ROCHELLE MANEY
- Address
- 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US
- Phone
- 770-770-7704
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SOLOGRIP III HANDPIECE | TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE | CRYOLIFE, INC. | MNO | HP-SG3 | TA-04069 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-11-17 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORT, THE WHITE CORD ON EACH OF THE HANDPIECES ARE CRACKED AND EXPOSING THE WIRE. THIS WAS NOTICED ONCE THESE 2 PRODUCTS WERE OPENED AND ABOUT TO BE USED IN A CASE. ADDITIONAL INFORMATION FROM THE NURSE DURING THE CASE STATED "THE FIRST ONE THEY TOOK OUT WENT TO USED IT ONCE I THINK THEY SAID AND THEN THEY DISCOVERED THE CRACK AND THEN AS THEY WERE MANIPULATING/INSPECTING IT, IT BEGAN TO CRACK IN MORE PLACES. THE SECOND ONE THEY OPENED AND INSPECTED AND LOOKED GOOD SO THEY USED IT AND DURING USE THEY AGAIN DISCOVERED IT HAD CRACKED ALSO. BOTH OF THESE ARE WELL WITHIN THEIR EXPIRATION DATES SO THERE SHOULD BE NO ISSUES THERE."
N
Patient 1
ACCORDING TO THE REPORT, THE WHITE CORD ON EACH OF THE HANDPIECES ARE CRACKED AND EXPOSING THE WIRE. THIS WAS NOTICED ONCE THESE 2 PRODUCTS WERE OPENED AND ABOUT TO BE USED IN A CASE. ADDITIONAL INFORMATION FROM THE NURSE DURING THE CASE STATED "THE FIRST ONE THEY TOOK OUT WENT TO USED IT ONCE I THINK THEY SAID AND THEN THEY DISCOVERED THE CRACK AND THEN AS THEY WERE MANIPULATING/INSPECTING IT BEGAN TO CRACK IN MORE PLACES. THE SECOND ONE THEY OPENED AND INSPECTED AND LOOKED GOOD SO THEY USED IT AND DURING USE THEY AGAIN DISCOVERED IT HAD CRACKED ALSO. BOTH OF THESE ARE WELL WITHIN THEIR EXPIRATION DATES SO THERE SHOULD BE NO ISSUES THERE." THE HOSPITAL RETURNED HANDPIECES TA-04069-(B)(4), TA-04069-(B)(4), AND TA-04069-(B)(4). THE HANDPIECES WERE VISUALLY INSPECTED. HANDPIECES SERIAL NUMBERS (B)(4) WERE OPENED AND (B)(4) HAD BEEN USED. HANDPIECE SERIAL NUMBER (B)(4) WAS UNOPENED AND WAS IN THE ORIGINAL PACKAGING; IT WAS SENT BACK AS IT WAS IN THE SAME LOT AS HANDPIECES (B)(4). IT WAS DETERMINED THAT THE HANDPIECES WOULD NOT BE SENT FOR DECONTAMINATION TO KEEP THE INTEGRITY INTACT. THE HANDPIECES WERE VISUALLY INSPECTED BY SUBJECT MATTER EXPERTS FROM RESEARCH & DEVELOPMENT. HANDPIECE (B)(4) WAS TRANSECTED IN NUMEROUS AREAS. ALL THE BROKEN AREAS WERE PROXIMAL TO THE HANDLE. THE WHITE SHEATH WAS BREAKING OFF FROM THE FIBER IN SMALL PIECES. HANDPIECE (B)(4) WAS NOTED TO HAVE DISCOLORATION ALL ALONG THE WHITE SHEATH DISTAL TO THE HANDLE. IT WAS TRANSECTED IN NUMEROUS LOCATIONS ALL ALONG THE SHEATH. BOTH HANDPIECES HAD RANDOM SPOTS ON THE SHEATH THAT WERE BRITTLE AND EASILY BREAKABLE. A 1" DILATOR WAS USED TO SEE HOW FLEXIBLE THE SHEATH WAS AND HOW EASILY IT WOULD BREAK IF WRAPPED AROUND AN OBJECT SUCH AS THE DILATOR. THE HANDPIECES WERE CONNECTED TO THE HENE (HELIUM-NEON) LASER TO TEST OUTPUT. BOTH HANDPIECES EFFECTIVELY DELIVERED LASER THROUGHOUT THE LENGTH OF THE HANDPIECES WITH NO BREAKS IN THE LASER FIBER. THE THUMB SLIDE MECHANISMS ON BOTH HANDPIECES WERE FUNCTIONAL AND THE FIBERS RETRACTED WITHOUT PROBLEM. HANDPIECE (B)(4) WAS NOT INSPECTED OUTSIDE OF THE PACKAGE. DISCOLORATION WAS NOTED THROUGH THE PACKAGING. THE UNOPENED HANDPIECE WAS RETURNED TO THE CONTRACT MANUFACTURER FOR FURTHER EVALUATION AS PART OF A CORRECTIVE/PREVENTIVE ACTION. THE EVALUATION RECEIVED FROM THE QUALITY CONTROL SUPERVISOR AT THE CONTRACT MANUFACTURER STATED THE FOLLOWING: "I WAS ABLE TO EVALUATE THIS UNIT ALONG WITH OUR MANUFACTURING LEAD AND ONE OF OUR IN-PROCESS INSPECTORS. VISUAL INSPECTION PRIOR TO OPENING POUCH AND TRAY: THERE WAS AN OBVIOUS CRACK IN THE TUBING (DISTAL END). THE TUBING HAD AN OBVIOUS DISCOLORATION (YELLOWING) AND APPEARED MORE NOTICEABLE ON THE PROXIMAL END OF THE TUBING. INSPECTION OF UNIT: THE TUBING CRACKED IN MULTIPLE PLACES AS I WAS SPIRALING AROUND THE CYLINDER. THIS CONDITION WAS IDENTICAL ON BOTH THE DISTAL AND PROXIMAL END. OBSERVATION: THE TUBING FELT HARD (BRITTLE) RIGHT OUT OF THE PACKAGE. THE TUBING WOULD ACTUALLY CRACK WITH JUST A LIGHT TOUCH WITHOUT SPIRALING. I CAN'T IMAGINE THAT TUBING IN THIS CONDITION COULD EVER MAKE IT THROUGH MANUFACTURING WITHOUT BEING NOTICED. SPECIFICALLY, THE PACKAGING PROCESS WHEN IT GETS COILED INTO THE TRAY." THE CONTRACT MANUFACTURER CONTACTED THE TUBING EXTRUDER, WHOSE RESPONSE WAS "THE CONCLUSION IS THAT WE HAVE NOT SEEN ANYTHING LIKE THIS IN ANY OF THE PRODUCTS THAT WE EXTRUDE IN HERE." THE MANUFACTURING RECORDS FOR LOT TA-04069 WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. THE LOT PASSED FUNCTIONAL TESTING AND MET CRYOLIFE RELEASE SPECIFICATIONS. NO ROOT CAUSE COULD BE IDENTIFIED.
D
Patient 1
ACCORDING TO THE REPORT, THE WHITE CORD ON EACH OF THE HANDPIECES ARE CRACKED AND EXPOSING THE WIRE. THIS WAS NOTICED ONCE THESE 2 PRODUCTS WERE OPENED AND ABOUT TO BE USED IN A CASE. ADDITIONAL INFORMATION FROM THE NURSE DURING THE CASE STATED "THE FIRST ONE THEY TOOK OUT WENT TO USED IT ONCE I THINK THEY SAID AND THEN THEY DISCOVERED THE CRACK AND THEN AS THEY WERE MANIPULATING/INSPECTING IT BEGAN TO CRACK IN MORE PLACES. THE SECOND ONE THEY OPENED AND INSPECTED AND LOOKED GOOD SO THEY USED IT AND DURING USE THEY AGAIN DISCOVERED IT HAD CRACKED ALSO. BOTH OF THESE ARE WELL WITHIN THEIR EXPIRATION DATES SO THERE SHOULD BE NO ISSUES THERE."