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

Model Number	1012454-20
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending artery.A 4.5x20mm nc trek rx balloon dilatation catheter (bdc) was prepared per instructions for use and with a 50/50 ratio contrast for post-dilatation.The bdc was inflated two times at 14 atmospheres; however, it was noted that the balloon did not deflate.A negative was held for 10 seconds, but the balloon only partially deflated.The bdc became caught on the non-abbott guide wire.All devices were removed as a unit.The procedure was successfully completed with an unspecified balloon catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult to remove was able to be confirmed.The reported deflation problem was unable to be replicated in a testing environment due to the condition of the returned device.A review of the lot history record identified no 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 from this lot.As there were no issues during the first inflation and deflation, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that an insufficient amount of time was not allowed to fully deflate the balloon and/or inadvertent mishandling resulted in the noted stretched and torn inner and outer member damages (thereby locking the guide wire and reducing the inflation/deflation lumen) thus resulting in the reported deflation problem and the reported difficult to remove.Manipulation of the device resulted in the noted multiple device damages further contributing to the reported difficulties (bunched balloon, separated/stretched inner member and proximal balloon marker, lifted guide wire exit notch, collapsed/twisted outer member, multiple hypotube bends).There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
Event or Problem Description
Additional information received confirmed that the balloon successfully deflated in between the two inflations.No additional information was provided.
Event or Problem Description
Additional information received indicating that the guide wire that became caught in the 4.5x20mm nc trek rx balloon dilatation catheter was an abbott vascular ht advance lite, not a non-abbott guide wire as initially reported.No additional information was provided.
Additional Manufacturer Narrative
The ht advance lite guide wire referenced in b5 and d11 is being filed under a separate medwatch report number.Concomitant product.

• 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: 10489690
• Report Number: 2024168-2020-07367
• Device Sequence Number: 2889085
• Product Code: LOX
• UDI-Device Identifier: 08717648152122
• UDI-Public: 08717648152122
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1012454-20
• Device Catalogue Number: 1012454-20
• Device Lot Number: 00714G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 09/14/2020; 11/04/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/22/2020; 11/24/2020
• 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: HT ADVANCE LITE; GUIDE WIRE: SION BLUE
• Patient Age: 61 YR