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

Catalog Number	1012445-08
Medical Device Problem Codes	Material Rupture (1546); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The mini trek device referenced in b5 is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a de novo, chronically totally occluded lesion in the heavily tortuous, heavily calcified, 100% stenosed mid right coronary artery.Although a non-abbott guide wire crossed, a 2 x 12 mm mini trek balloon dilatation catheter (bdc) failed to cross due to the anatomy.However, the bdc was inflated proximal to the lesion, and the balloon ruptured during the second inflation at 14 atmospheres (atms).The device was replaced with a 2 x 8 mm nc trek bdc, which also failed to cross due to the anatomy and was inflated proximal to the lesion, but this balloon ruptured during the third inflation at 18 atms.The device was replaced with a non-abbott balloon, but that device also ruptured.The procedure ended without any further intervention.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001.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 similar incidents and/or complaints from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8913144
• Report Number: 2024168-2019-11002
• Device Sequence Number: 16275059
• Product Code: LOX
• UDI-Device Identifier: 08717648151637
• UDI-Public: 08717648151637
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103153
• 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): 09/12/2019

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: 02/28/2022
• Device Catalogue Number: 1012445-08
• Device Lot Number: 90306G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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: HYPERION SAL1.5 GUIDE CATHETER; SION BLUE GUIDE WIRE; XT-R GUIDE WIRE
• Patient Age: 58 YR
• Patient Weight: 76