MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-04-14 for MEDTRONIC REUSABLE EXTENSION CABLE 59312 manufactured by Oscor Inc..
[72882298]
This report is part of an internal retrospective review of complaints, conducted by oscor as a result of process improvements made to the complaint system to ensure proper medical device reporting is maintained. As part of the detailed review, this event has been determined to be reportable. This initial mdr is being submitted to meet our requirements of reporting. Product analysis report was processed on (b)(4). A kink was observed on the positive cable. This could have been caused by either the handling of the device by the customer or doctor. There was also a black scuff mark on the strain relief of the positive cable. The scuff mark appears in line with the end of the electrode pin. This could have been caused by some sort of impact with another object such as the ground or from the use of a tool to remove the pin. After the strain relief was carefully removed from the positive electrode pin, it was found that the wires in the cable were no longer attached to the pin, which explains the failure to pace. Also, the end of the pin where the wires are connected was out of round compared to the negative electrode pin. This was due to two dents on either side of the pin. This looks like it could have been caused by teeth on a pair of pliers. If there was problem with the pin after final assembly, the part would have been rejected because these parts are inspected 100 percent for continuity and function of the pin. Per the cable inspection procedure 4b-51-006z-e, during in process inspection the cable is inspected 100% for continuity. During final inspection, each strand of the cable is checked for the correct colored part, overall length of the cable, cable checked for damage and insulation voids, verification that the silicone strain relief extends at least for a length of 2 cm outside the female connector, checked that the silicone strain relief fits the wire snugly, checks for strain relieves for damage and gaps, a pull test is done on each connector and pin, and the cable is inspected again for continuity. The returned device analysis reveals that the atar mdts extension cable is within manufacturing specifications. No manufacturing defects were found. The reason for return cannot be confirmed. The instructions for use (ifu) ma-17-005z-x informs the user: for reusable cables only: the cables can be re-sterilized by oscor eto gas sterilization a maximum of two times. The directions for use inform the user to: first attach the proximal connector(s) to a pacemaker/analyzer or another extension cable while observing polarity indicated by the color. Then attach the distal connector(s) to the temporary lead connector or to another extension cable, again observing polarity by the color. The detachment of the connection should be done in the reverse order. Precautions include: do not connect any cable model to a/c power source; connection of exposed pins to a/c power source may pose a risk of serious injury or death. Extension cables are not intended for use with apnea monitors.
Patient Sequence No: 1, Text Type: N, H10
[72882299]
During a trans-catheter aortic valve replacement (tavr) case the external pulse generator (epg) failed to rapid atrial pace. When epg connected to new cable appropriate pacing occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2017-00030 |
| MDR Report Key | 6494321 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-04-14 |
| Date of Report | 2017-04-14 |
| Date of Event | 2015-02-09 |
| Date Mfgr Received | 2015-02-09 |
| Date Added to Maude | 2017-04-14 |
| 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 | MS. DORIT SEGAL |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 346831816 |
| Manufacturer Country | US |
| Manufacturer Postal | 346831816 |
| Manufacturer G1 | OSCOR INC. |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 346831816 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 346831816 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC REUSABLE EXTENSION CABLE |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-04-14 |
| Model Number | 59312 |
| Catalog Number | 59312 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSCOR INC. |
| Manufacturer Address | 3816 DESOTO BLVD. PALM HARBOR FL 346831816 US 346831816 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-14 |