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

Catalog Number	1012451-20
Medical Device Problem Codes	Inflation Problem (1310); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
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.Evaluation summary: a visual inspection was performed on the returned device.The hypotube was separated 0.5 mm distal to the hub.The strain relief tubing was kinked at the same location as the separation but was still intact.The reported inflation issue was unable to be confirmed because the balloon was not able to be tested because of the condition of the device.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 did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported inflation issue because of the condition of the returned device.Although a conclusive cause for the inflation issue could not be determined, the noted damages appear to be related to operational circumstances of the procedure as it is likely that manipulation and/or mishandling as well as the difficult anatomy contributed to the hypotube detachment.There was no damage noted to the balloon catheter during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mid right coronary artery with moderate tortuosity, heavy calcification and 90% stenosis.A 3.5 x 20 mm nc trek rx balloon dilatation catheter (bdc) was advanced to the lesion for pre-dilatation; however, on attempting to inflate the balloon to the rate of burst pressure (rbp) the balloon completely failed to inflate.A non-abbott 3.5 x 20 mm balloon catheter was used to successfully pre-dilate the lesion prior to the deployment of a 3.5 x 48 mm xience xpedition stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Returned goods analysis identified that the hypotube was separated 0.5 mm distal to the hub.The strain relief tubing was kinked at the same location as the separation but was still intact.

• 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: 8251110
• Report Number: 2024168-2019-00376
• Device Sequence Number: 16542556
• Product Code: LOX
• UDI-Device Identifier: 08717648151996
• UDI-Public: 08717648151996
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

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: 05/31/2020
• Device Catalogue Number: 1012451-20
• Device Lot Number: 70601G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1