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

Catalog Number	1012280-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).Visual inspections were performed on the returned device.The reported separation was confirmed.The reported resistance with the hemostatic valve during removal was not tested due to the condition of the returned device.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 resistance with the hemostatic valve; however the reported separation 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 a 5.0x12mm trek rx balloon dilatation catheter (bdc) was unpackaged and prepped without issue.The trek rx bdc was then advanced without resistance to a lesion in the saphenous vein graft (svg) to the right coronary artery (rca) and dilatation was successfully completed.The trek rx bdc was then retracted without difficulty from the anatomy and through the guiding catheter, however, during retraction through the non-abbott hemostatic valve, resistance was felt against the valve and the entire trek rx balloon detached (separated) from the distal shaft at the proximal balloon seal.As the separated piece was located outside of the valve, it was simply withdrawn from the valve.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.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: 6345625
• Report Number: 2024168-2017-01393
• Device Sequence Number: 13561351
• Product Code: LOX
• UDI-Device Identifier: 08717648138775
• UDI-Public: (01)08717648138775(17)180531(10)50617G1
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

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: 05/31/2018
• Device Catalogue Number: 1012280-12
• Device Lot Number: 50617G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2017
• Initial Report FDA Received Date: 02/21/2017
• 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: RHV: TUOHY BORST HEMOSTATIC VALVE
• Patient Age: 69 YR
• Patient Weight: 107