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

Catalog Number	1012405-15
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/11/2016
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 received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported during unpacking of the otw 2.5 x 15 mm trek balloon dilatation catheter, the vendor seal of the pouch was already opened.Therefore, the device was not used.Another trek balloon was used in the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned with the pouch having been opened.The observed cloudy appearance in the seal area of the returned devices demonstrates that the seals originally existed at some point.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 similar incidents from this lot.There is no evidence to indicate that a wider population of product has potentially been impacted.The performance of these devices will continue to be monitored.

• 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: 5845294
• Report Number: 2024168-2016-05148
• Device Sequence Number: 18944082
• Product Code: LOX
• UDI-Device Identifier: 08717648153983
• UDI-Public: (01)08717648153983(17)180630(10)50720G1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 09/02/2016

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: 06/30/2018
• Device Catalogue Number: 1012405-15
• Device Lot Number: 50720G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 09/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1