MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-07 for ACHIEVE ELECTRICAL CABLE 990066 manufactured by Medtronic Cryocath Lp.
[27960077]
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 Sequence No: 1, Text Type: N, H10
[27960078]
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 Sequence No: 1, Text Type: D, B5
[29373504]
Patient Sequence No: 1, Text Type: N, H10
[30488136]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[31056535]
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 Sequence No: 1, Text Type: N, H10
[104674257]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002648230-2015-00336 |
| MDR Report Key | 5131835 |
| Date Received | 2015-10-07 |
| Date of Report | 2015-09-25 |
| Date of Event | 2015-09-25 |
| Date Mfgr Received | 2015-11-05 |
| Device Manufacturer Date | 2015-06-09 |
| Date Added to Maude | 2015-10-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNE SCHILLING |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635052036 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM HEART FAILURE |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | CVG-16-Q2-12 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACHIEVE ELECTRICAL CABLE |
| Generic Name | CABLE |
| Product Code | ISN |
| Date Received | 2015-10-07 |
| Returned To Mfg | 2015-10-09 |
| Model Number | 990066 |
| Catalog Number | 990066 |
| Lot Number | U531 |
| Device Expiration Date | 2017-06-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC CRYOCATH LP |
| Manufacturer Address | 16771 CHEMIN STE-MARIE KIRKLAND H9H 5H3 CA H9H 5H3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-07 |