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

Catalog Number	1012278-30
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The asahi fielder xt is filed under a separate medwatch report number.Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported difficulty removing the bdc from the guide wire was confirmed.The investigation was unable to determine a conclusive cause for the reported difficulty.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.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 this was an emergent procedure to treat a 100% clotted saphenous graft to the obtuse marginal.A thrombectomy with angiojet was performed.Then, the trek rx 4.0 x 30 mm balloon dilatation catheter was advanced over the xt fielder guide wire and inflated 3 times to 14 atmospheres but when the trek rx was being removed, it froze on the wire.The balloon was fully deflated prior to removal.Both devices were removed as a single unit.There was no reported resistance during removal of the stylet or protective sheath.There were no adverse patient effects and no clinically significant delay.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: 6315865
• Report Number: 2024168-2017-01089
• Device Sequence Number: 675736
• Product Code: LOX
• UDI-Device Identifier: 08717648138744
• UDI-Public: (01)08717648138744(17)190331(10)60430G1
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/09/2017

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: 03/31/2019
• Device Catalogue Number: 1012278-30
• Device Lot Number: 60430G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2017
• Initial Report FDA Received Date: 02/09/2017
• 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: GUIDE WIRE: ASAHI FIELDER XT
• Patient Age: 70 YR