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

Catalog Number 1012445-12

Device Problems Inflation Problem (1310); Difficult to Remove (1528); Material Separation (1562); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical produts: vessel closure: 3 proglides.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 circumflex and left anterior descending artery during a kissing balloon technique.A 2.0 x 12 mm nc trek balloon catheter was used and did not meet any resistance during advancement.However, the balloon completely failed to inflate and a hissing noise was reported.Additionally, the device met resistance during removal with the anatomy, and the shaft near the hub separated.Therefore, the device was removed independently and another 2.0 x 12 mm nc trek balloon catheter was used without issues.However, the patient expired 50 minutes post procedure.It was reported that the nc trek balloon catheter did not cause or contribute to the death.It was reported that the death was due to a retroperitoneal bleed caused by the 14fr sheath and dilator.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported separation was confirmed.The reported inflation issue and device operated differently (hissing noise) could not be replicated in a testing environment due to the condition of the returned device.The reported difficulty to remove could not be replicated in a testing environment as it was based on operational circumstances.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 incidents from this lot.The investigation was unable to determine a conclusive cause for the reported inflation issue and device operated differently (hissing noise); however, the reported separation and difficulty removing the device appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects 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: 8514482
• MDR Text Key: 141946463
• Report Number: 2024168-2019-02910
• 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,health
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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: 06/30/2020
• Device Catalogue Number: 1012445-12
• Device Lot Number: 70706G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 09/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 90