MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-08-15 for LEAD ADAPTOR BIS/IS-15 manufactured by Oscor Inc..
[117217635]
The adaptor was used in treatment. It was explanted due to an infection and it was not returned for analysis, therefore a root cause could not be determined. The investigation will focus on review of product documentation. No allegation our device failed to meet its performance specifications or caused or contributed to the infection. Proof of sterilization is on file. Infection is a recognized clinical event referenced in the device's labeling and/or reported in the medical literature. The device history record was reviewed to confirm that the device passed all applicable in-process and final inspections. A review of complaints against this sterilization lot number identified no additional complaints. Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing nonconformity or new failure mode. Oscor will continue to monitor this event type. Per qa procedure final labeling/packaging inspection of all products: all labeling and packaging will be inspected 100%. Check for foreign material and tyvek seal integrity. Verify that color of steri-dot changed from brown to green, where applicable. Sealed areas (tyvek lid to lip of tray and pouch) are continuous around entire perimeter of tray. No voids, breaks, and or bubbles along the seal. The entire seal should be at least? Inch wide and have a full ridge. The tyvek pull tab must be properly folded into position. Examine the seal and border for uniformity of the seal. Check for holes or any other damages that could violate sterility. The bipolar pacing lead adaptors self-sealing instructions for use (ifu) informs the user lead adaptors are indicated for connecting the existing pacing lead(s) to a compatible pacemaker header cavity. Cautions: device is supplied sterile. Do not use if package has been previously opened or damaged. Prior to use, read all package inserts, warnings, precautions, and instructions. Failure to do so may result in severe patient injury or death. Procedure must be performed by trained medical personnel well versed in anatomical landmarks, safe technique, and potential complications. The device is designed for single use only. Do not resterilize or reuse. Do not alter the device in any way. No adverse effects known. Possible complications: infection. As with the introduction of any foreign object into the body, an infection might result.
Patient Sequence No: 1, Text Type: N, H10
[117217636]
The customer reported "complete system extracted due to infection. ". Device/lead sns (b)(4) were removed on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2018-00073 |
| MDR Report Key | 7786723 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-08-15 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-07-05 |
| Date Mfgr Received | 2018-08-21 |
| Device Manufacturer Date | 2016-10-14 |
| Date Added to Maude | 2018-08-15 |
| 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 DE SOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 34683 |
| Manufacturer Country | US |
| Manufacturer Postal | 34683 |
| Manufacturer Phone | 7279372511 |
| Manufacturer G1 | OSCOR INC. |
| Manufacturer Street | 3816 DE SOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 34683 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34683 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD ADAPTOR |
| Generic Name | PACEMAKER LEAD ADAPTOR |
| Product Code | DTD |
| Date Received | 2018-08-15 |
| Model Number | BIS/IS-15 |
| Catalog Number | BIS/IS-15 |
| Lot Number | C4-13107 |
| Device Expiration Date | 2019-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSCOR INC. |
| Manufacturer Address | 3816 DE SOTO BLVD. PALM HARBOR FL 34683 US 34683 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-08-15 |