| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ADAP-2000 DISPOSABLE PACING CABLE | PACEMAKER, EXTERNAL, TEMPORARY | REMINGTON MEDICAL, INC. | DSA | ADAP-2000 | ADAP-2000 | 113623 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-06-28 | 0 |
Patient 1
PER (B)(4): "EVENT DESC: THE NURSE WAS ATTEMPTING TO INSERT A PACEMAKER ADAPTER CABLE INTO THE PACEMAKER. ADAPTER HAD OBVIOUS MALFORMATION THAT PROHIBITED CABLE FROM FULLY INSERTING INTO THE PACEMAKER." "DEVICE USAGE PROBLEM: DEVICE FAILED (E.G., BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)."
Patient 1
THIS COMPLAINT WAS REVIEWED BY RMI WITH (B)(6) ON (B)(4) 2012. (B)(6) WAS UNABLE TO PROVIDE MUCH DETAIL BEYOND WHAT IS STATED IN (B)(4). (B)(6) SUGGESTED THAT WE REVIEW THIS COMPLAINT WITH (B)(6). (B)(6) STATED THAT THE DEVICE WAS FOUND TO BE UNUSABLE DUE TO THE MALFORMED SHAPE OF THE PIN CONNECTOR (97 PIN CONNECTOR). THE HOSPITAL STAFF SET ASIDE THE CABLE AND USED THE NEXT AVAILABLE CABLE WITHOUT INCIDENT. (B)(6) TOOK PHOTOGRAPHS AND PROVIDED THEM TO US FOR REVIEW. (B)(6) ALSO CONFIRMED THAT THERE WAS NO PT INJURY. REMINGTON INITIATED A RETURN GOODS AUTHORIZATION (RGA) AND RECEIVED THE DEVICE FOR ANALYSIS. AN INITIAL INSPECTION OF THE RETURNED SHOWED A SLIGHTLY DEFORMED AND SHINY 97 PIN CONNECTOR, SIMILAR TO WHAT WOULD BE EXPECTED OF A DEVICE EXPOSED TO HEAT. THE DEVICE HISTORY RECORD (DHR) AND WORK ORDER FOR THIS SPECIFIC LOT (113623) WERE REVIEWED AND NO ISSUES WERE FOUND THAT WOULD INDICATE A POTENTIAL CAUSE OF THE CABLE DEFECT IN THE MFG OR INSPECTION PROCESSES. THIS LOT OF CABLES WAS 100% INSPECTED AND TESTED, INCLUDING INSERTING THE CABLE INTO MATING COMPONENTS FOR CONNECTIVITY AND FIT VERIFICATION. FOLLOWING A REVIEW OF THE DHR, SEVERAL ADAP-2000 CABLES WERE REMOVED FROM FINISHED GOODS INVENTORY AND SUBJECTED TO ELEVATED TEMPERATURES FROM A VARIETY OF POSSIBLE SOURCES IN AN ATTEMPT TO REPLICATE THE CONDITION OF THE RETURNED CABLE. THE 97 PIN CONNECTOR CHANGED IN PHYSICAL APPEARANCE (DEFORMATION AND INCREASED SHINE OR GLOSS). WHILE NOT IDENTICAL, THE 97 PIN CONNECTOR APPEARED TO BE VERY CLOSE TO THE RETURNED CABLE IN SHAPE AND FINISH. BASED ON THE RESULTS OF THE EXPOSURE OF THE TEST CABLES TO HEAT, WE CONCLUDED THAT THE RETURNED CABLE HAD MOST LIKELY BEEN EXPOSED TO SOME TYPE OF HEAT SOURCE, EITHER BY AUTOCLAVING OR SOME OTHER MEANS AFTER LEAVING THE CONTROL OF RMI. IN AN EFFORT TO DETERMINE IF THE CUSTOMER MAY HAVE KNOWINGLY EXPOSED THE CABLE TO A HEAT SOURCE, REMINGTON INQUIRED IF THE CUSTOMER PERFORMS ANY RE-PROCESSING OR AUTOCLAVING. THE CUSTOMER CLAIMS THAT THEY DO NOT RE-PROCESS THESE CABLES.