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

Catalog Number	1012448-15
Medical Device Problem Codes	Leak/Splash (1354); Product Quality Problem (1506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
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 incident information was reviewed; however, the product was not returned to abbott vascular for analysis.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 revealed no other similar incidents.The investigation was unable to determine a conclusive cause for the reported damaged device and leak.It is possible that manipulation and/or inadvertent mishandling of the device during unpacking likely caused the damage to the device resulting in the possible leak at the damage location; however, this could not be confirmed.Return of the device or if additional information from the account may have further aided the analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the balloon of a 2.75x15mm nc trek balloon dilatation catheter (bdc) was found to be damaged after unpacking.A check for leaks was made; however, the results were not provided.The procedure was successfully completed with an unspecified 2.75x15mm device.There were no adverse patient effects.There was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: NC 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: 8269225
• Report Number: 2024168-2019-00502
• Device Sequence Number: 14025407
• Product Code: LOX
• UDI-Device Identifier: 08717648151828
• UDI-Public: 08717648151828
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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: 07/31/2020
• Device Catalogue Number: 1012448-15
• Device Lot Number: 70814G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1