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

Catalog Number	1012403-08A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2017
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 products: guide wire: sion, sionblue, xt-r.Guide catheter: hyperion.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 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.
Event or Problem Description
It was reported that the procedure was to treat a concentric, heavily calcified, 99% stenosed lesion in the mildly tortuous distal right coronary artery (rca).A 2.0x8mm mini trek ii otw balloon dilatation catheter (bdc) was unpackaged and prepped outside of patient anatomy without issue.The bdc was then advanced over a non-abbott guide wire, into a non-abbott guiding catheter and to the lesion, with resistance felt against the proximal part of the lesion; tapping technique was used to facilitate crossing of the lesion.During inflation, the balloon ruptured at 8 atmospheres.The bdc was withdrawn without resistance.An attempt was then made to perform dilatation with a non-abbott balloon, but this balloon also ruptured.The resulting stenosis was 75% and no further attempts were made to treat the lesion as further dilatation of this lesion is considered impossible.There were no adverse patient effects and no occurrence of clinically significant delay.No additional information was provided.

• Brand Name: MINI TREK II OTW 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: 6603456
• Report Number: 2024168-2017-04663
• Device Sequence Number: 1169998
• Product Code: LOX
• UDI-Device Identifier: 08717648180866
• UDI-Public: (01)08717648180866(17)180930(10)51006G1
• 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): 05/31/2017

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: 09/30/2018
• Device Catalogue Number: 1012403-08A
• Device Lot Number: 51006G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1