MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012276-12
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.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 incidents reported from this lot.In this case, the device was prepped prior to use without issue/ leak noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture appear to be related to operational circumstances of the procedure.It is likely that during the second inflation, the balloon outer surface became compromised and/or damaged against the anatomy resulting in the balloon rupture.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.
Event or Problem Description
It was reported the procedure was to treat a 90% stenosed, mildly tortuosity, and moderately calcified de novo lesion in the left anterior descending artery (lad).A 3.50x12mm trek rx balloon dilatation catheter (bdc) was prepped outside the anatomy prior to use without any issues.The bdc was advanced without resistance and the balloon was inflated twice; however, it ruptured below rate of burst pressure at 10 atmospheres.The procedure was successfully completed with a non-abbott device.There were no adverse patient effects and no clinically significant delay reported in the procedure.No additional information was provided.

• 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: 10525395
• Report Number: 2024168-2020-07628
• Device Sequence Number: 2720386
• Product Code: LOX
• UDI-Device Identifier: 08717648138560
• UDI-Public: 08717648138560
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 09/11/2020

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: 12/31/2021
• Device Model Number: 1012276-12
• Device Catalogue Number: 1012276-12
• Device Lot Number: 90129G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1