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

Catalog Number	1012405-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant product: guide wire: hi-torque balance middleweight universal ii 300cm.Visual inspections were performed on the returned device.The reported separation was confirmed.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 identified no other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.Reportedly force was used when encountering resistance during removal.It should be noted that the trek rx and mini trek rx, global instruction for use states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.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 treat a moderately calcified lesion in the moderately tortuous right coronary artery (rca).After advancing a hi-torque (ht) balance middleweight (bmw) universal ii 300cm guide wire (gw) past the lesion without difficulty, a 2.5x15mm trek otw balloon dilatation catheter (bdc) was unpackaged and prepped without issue and was advanced over the gw and to the lesion without resistance.The lesion was successfully pre-dilated with the trek otw bdc, however, after deflation, without difficulty, the bdc was very difficult to retract over the gw.As the physician did not want to lose lesion positioning by withdrawing both devices as a single unit, the trek otw bdc was retracted over the gw against resistance.With the same gw still in place, a non-abbott stent system was advanced, the stent was deployed, and the system was withdrawn over the gw without resistance.While a half-hour delay occurred, it did not result in a health impact.There were no adverse effects.No additional information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: 6511896
• Report Number: 2024168-2017-03474
• Device Sequence Number: 16340757
• Product Code: LOX
• UDI-Device Identifier: 08717648153983
• UDI-Public: (01)08717648153983(17)190430(10)60505G1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2017

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: 04/30/2019
• Device Catalogue Number: 1012405-15
• Device Lot Number: 60505G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/21/2017
• 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: CONCOMITANT MEDICAL DEVICES
• Patient Age: 89 YR
• Patient Weight: 75