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

Catalog Number	1012276-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2017
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.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 was unable to determine a conclusive cause for the reported deflation issue.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 non-tortuous, non-calcified lesion in the distal left main (lm) coronary artery.An unspecified stent was placed in the lm into the left anterior descending (lad) artery.Kissing balloon angioplasty was performed with two trek balloon dilation catheters (bdc) for the bifurcated lesion.A 3.5 x 12 mm trek bdc was first placed in the lm to lad and inflated at 12 atmospheres for 10 seconds.The second 3.0 x 15 mm trek bdc was placed in the lm to circumflex (cx) and inflated at 16 atmospheres for 7 seconds.During deflation, it was noted that the 3.5 x 12 mm trek deflated partially.The entire system was removed, including the guiding catheter and both a sion blue asahi guide wire and a non-abbott guide wire.The trek was withdrawn partially inflated.The procedure was successfully completed by post-dilating the lm with a non-abbott balloon.There was no harm done to the patient.There was no clinically significant delay in procedure and no adverse patient effects.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: 6930263
• Report Number: 2024168-2017-08055
• Device Sequence Number: 16449907
• Product Code: LOX
• UDI-Device Identifier: 08717648138560
• UDI-Public: 08717648138560
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/09/2017

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: 01/31/2020
• Device Catalogue Number: 1012276-12
• Device Lot Number: 70220G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR