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

Catalog Number 1012447-12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The graftmaster device referenced is being filed under a separate medwatch report.

Event Description

It was reported that the procedure was performed to treat an 80% stenosed, mildly tortuous and mildly calcified lesion in the left circumflex coronary artery.A 2.5x12mm nc trek balloon dilatation catheter was used without reported issue to performed pre-dilatation; however, a lesion rupture [perforation] was found after pre-dilatation was performed.A 2.8x19mm graftmaster coronary stent graft system was then advanced but could not cross due to the anatomy.A non-abbott coronary stent graft system was then used to treat the perforation.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of perforation is listed in the coronary dilatation catheters, nc trek rx, global, instruction for use as known patient effects.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.Additionally, the additional treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 8692239
• MDR Text Key: 147761710
• Report Number: 2024168-2019-04631
• 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: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 1012447-12
• Device Lot Number: 71218G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention