MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number	1012455-15
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat an st elevation myocardial infarction (stemi) patient.Two stents were placed in the vein graft.The 5.0x15 mm nc trek balloon dilatation catheter (bdc) was used for post dilatation.Multiple inflations were performed.The balloon did not deflate, the bdc would not pull back into the guide catheter.Different attempts were made to remove the bdc; however, in the end the balloon snapped off inside the guide catheter.The devices were removed as a single unit.After all this, the implanted stents were observed to be damaged.Two additional stents were implanted, covering the damaged stents.The patient was stable and the procedure was finished safely.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.Visual and functional inspections were performed on the returned device.It was observed that outer member was stretched at the mid lap seal.The reported separation was confirmed.The reported deflation issue and difficulty removing the device from the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.The reported device damaged by another device could not be confirmed.A review of the lot history record identified one manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The reported difficulty removing the device from the guiding catheter, separation, device damaged by another device and additional treatment appear to be related to operational context.The investigation determined the noted stretched outer member at the mid lap seal and reported deflation issue appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9950536
• Report Number: 2024168-2020-03577
• Device Sequence Number: 11593158
• Product Code: LOX
• UDI-Device Identifier: 08717648152153
• UDI-Public: 08717648152153
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 1012455-15
• Device Catalogue Number: 1012455-15
• Device Lot Number: 00206G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE; GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR