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

Catalog Number	1012271-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: guide wire: sion blue, guide catheter: launcher 6fr al1.0.The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint additionally, a review of the complaint history revealed no similar incidents.The investigation determined the reported balloon rupture appears to be related to circumstances of the procedure.Based on the information reviewed, 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 to threat a lesion in the mid left anterior descending (lad) artery with mild tortuosity and heavy calcification that was 90% stenosed.Resistance was not felt during the advancement of the 2.25mm x 12 mm trek rx balloon dilatation catheter (bdc) for pre-dilatation and it crossed the lesion successfully; however, during the first inflation, the balloon would not fully inflate when the pressure was increased to 10 atmospheres and held for 20 seconds.A second inflation was then attempted, but the balloon ruptured at 12 atmospheres.A new non-abbott bdc was used for pre-dilatation and the procedure was successfully completed after a stent was implanted.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.

• Brand Name: 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: 6527273
• Report Number: 2024168-2017-03677
• Device Sequence Number: 11021183
• Product Code: LOX
• UDI-Device Identifier: 08717648138218
• UDI-Public: (01)08717648138218(17)190731(10)60813G1
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2017

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: 07/31/2019
• Device Catalogue Number: 1012271-12
• Device Lot Number: 60813G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1