| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ACHIEVE ELECTRICAL CABLE | CABLE | MEDTRONIC CRYOCATH LP | ISN | 990066 | 990066 | U531 | N | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-10-07 | 0 |
Patient 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4)
Patient 1
IT WAS REPORTED THAT PRIOR TO USE, MULTIPLE MAPPING CATHETER ELECTRICAL CABLES WERE RECEIVED MISSING THE OUTER BOX SEAL. IT WAS NOTED THAT UPON OPENING THE CATHETERS, THERE WAS A BREACHED INNER STERILE PACKAGE WITH CABLES THAT WERE LABELED WITH TAPE. THE CABLES WERE REPLACED AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient 1
Patient 1
(B)(4)
Patient 1
PRODUCT EVENT SUMMARY: THE ACHIEVE ELECTRICAL CABLE WAS RETURNED AND ANALYZED. THE CABLE WAS RECEIVED IN ITS ORIGINAL PACKAGING BOX WITH A MISSING TAMPERING SEAL AND AN OPENED STERILE PACKAGE POUCH. VISUAL INSPECTION OF THE CABLE SHOWED THAT THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. IT WAS NOTED THAT SOME UNITS WERE OBSERVED WITH A HAND WRITTEN TAG AND MASKING TAPE. NO PERFORMANCE TESTING WAS CONDUCTED WITH THESE UNITS. ALSO, THE UNITS WERE FOR QUALIFICATION TESTING AND WERE NOT INTENDED CLINICAL USE. A PRODUCT HOLD ORDER (PHO) AND A FIELD ACTION WAS INITIATED. IN CONCLUSION, THE REPORTED ISSUE OF THE COMPROMISED AND OPENED PACKAGING WAS CONFIRMED THROUGH TESTING. THE CABLE FAILED THE INSPECTION DUE TO AN OPEN BOX AND POUCH.
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.