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

Catalog Number 1012447-12

Device Problems Material Rupture (1546); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported the procedure was performed to treat a de novo, narrow lesion with severe stenosis 80% and very calcified in the proximal left anterior descending (lad) coronary artery.A 2.5 x 12 mm nc trek balloon catheter was advanced with resistance to the target lesion for pre-dilatation.The balloon was inflated to 12 atmospheres for 12 seconds; however, the balloon started to deflate due to a pinhole.Pre-dilatation was not satisfactory; therefore, rotablation was planned for a new procedure.There was no adverse patient effect and no clinically significant delay in the procedure.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 resistance during advancement could not be replicated in a testing environment as it was based on operational circumstances.The reported balloon rupture was confirmed.The investigation determined the reported resistance during advancement and balloon rupture appears to be related to anatomical conditions.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: NC 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: 8196739
• MDR Text Key: 131488593
• Report Number: 2024168-2018-10036
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K110134
• 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: 01/14/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 1012447-12
• Device Lot Number: 81009G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1