MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK RX OTW LIMITED INDICATION; CORONARY DILATATION CATHETER

Model Number	1012402-20A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 from this lot.However as the device was not returned for analysis, the investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the moderately tortuous, 99% stenosed distal right coronary artery.A 1.5x20mm mini trek ii balloon dilatation catheter (bdc) was advanced without resistance, but the balloon ruptured during the first inflation at 8 atmospheres.A 1.5x15mm non-abbott balloon 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.

• Brand Name: MINI TREK RX OTW LIMITED INDICATION
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10233154
• Report Number: 2024168-2020-05473
• Device Sequence Number: 18981113
• Product Code: LOX
• UDI-Device Identifier: 08717648180842
• UDI-Public: 08717648180842
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2020

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: 12/31/2020
• Device Model Number: 1012402-20A
• Device Catalogue Number: 1012402-20A
• Device Lot Number: 80126G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1