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

Catalog Number 1012270-12

Device Problems Kinked (1339); Leak/Splash (1354); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number -(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 Description

It was reported that the procedure was to treat a moderately tortuous and moderately calcified left anterior descending artery.During loading of a 2.0 x 12 mm mini trek balloon catheter onto an unspecified guide wire, prior to the balloon entering the patient, the guide wire would not cross the mid shaft of the balloon.It was noticed that the balloon catheter was kinked.Afterwards, an attempt was made to inflate the balloon and a leak was noted from the distal tip.A new unspecified trek balloon was used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The reported leak was confirmed.The reported difficulty positioning the guide wire and kink were not confirmed.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 identified no other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as return analysis noted that there was a hole puncture in the inner member and the balloon proximal to the distal balloon marker, due to the insertion of the guide wire which subsequently lead to the difficulty positioning the guide wire in the device, the reported leak and the perception of a kink.There is no indication of a product quality issue with respects to the design, manufacturing, or labeling of the device.

• Brand Name: MINI TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7252722
• MDR Text Key: 99937914
• Report Number: 2024168-2018-00928
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 1012270-12
• Device Lot Number: 71109G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2018
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1