MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012271-08
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.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 a moderately tortuous, moderately calcified left anterior descending artery.A 2.25x8mm trek balloon was being advanced when a fracture was noted in the middle and beginning of the shaft.The device was removed and another non-abbott device was used to successfully complete the procedure.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 and it was noted there was a leak and a tear in the outer member distal to the guide wire exit notch.The reported deformation due to compressive stress was able to be confirmed.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 was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement inadvertent mishandling and/or interaction with other devices resulted in the reported/noted device damages (multiple bends, outer member tear); thus resulting in the noted leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.Device code correction: code 1069 was removed.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, moderately calcified left anterior descending artery.A 2.25x8mm trek balloon was being advanced when a fracture was noted in the middle and beginning of the shaft.The device was removed and another non-abbott device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to filing the initial report, additional information was received from the account confirming that by 'catheter fracture' it meant that the shaft kinked in two parts, and was not fractured/broken.No additional information was provided.Device analysis noted there was a leak and a tear in the outer member distal to the guide wire exit notch.

• Brand Name: 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: 10494450
• Report Number: 2024168-2020-07394
• Device Sequence Number: 14348514
• Product Code: LOX
• UDI-Device Identifier: 08717648138201
• UDI-Public: 08717648138201
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: 07/31/2020
• Device Model Number: 1012271-08
• Device Catalogue Number: 1012271-08
• Device Lot Number: 70814G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 79