MAUDE Adverse Event Report: AV-TEMECULA-CT MINI TREK CORONARY DILATATION CATHETER

Catalog Number	1012269-06
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical product: guiding catheter: hyperion 8fr al 1.5.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 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 respect to design, manufacture or labeling of the device.The nc trek rx is filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, heavily calcified, concentric, and de novo mid right coronary artery that was 100% stenosed.An unspecified guidewire advanced to the lesion, but a 1.5 x 6 mm rx mini trek balloon catheter met resistance during advancement and could not cross due to the anatomy.The mini trek balloon catheter was removed with resistance and replaced with a non-abbott balloon catheter.Then the lesion was pre-dilatated with a non-abbott balloon, and a 3.25 x 15 mm nc trek balloon was used for further dilatation.The nc trek balloon met resistance during advancement due to the anatomy, but reached the target lesion and during first inflation the nc trek balloon ruptured at 10 atmospheres.The nc trek balloon was removed with resistance due to the anatomy.A rotablator and an unspecified xience stent was deployed to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: MINI TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7286484
• Report Number: 2024168-2018-01276
• Device Sequence Number: 16561808
• Product Code: LOX
• UDI-Device Identifier: 08717648138072
• UDI-Public: 08717648138072
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

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: 04/30/2020
• Device Catalogue Number: 1012269-06
• Device Lot Number: 70525G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 41