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

Catalog Number 1012270-12

Device Problems Peeled/Delaminated (1454); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2019

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 was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that this was a percutaneous intervention treating a mildly tortuous, circumflex (cx) coronary artery with severe calcification.A mini trek dilatation catheter advanced with some resistance to the lesion.It was initially thought that the resistance was due to anatomy.Inflation was performed without issues three times.The dilatation catheter was removed from the anatomy without noted resistance.Once outside the anatomy, the hydrophilic coating on the dilatation catheter appeared to have come off the catheter.Reportedly, this could have contributed to the resistance during advancement.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.

Manufacturer Narrative

Internal file number - (b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.If follow-up what type corrections: contact name, foreign unselected.Internal file number - (b)(4).Evaluation summary: visual inspection and chemical analysis was performed.The reported peeled (coating) and physical resistance complaints could not be replicated in a testing environment as it was based on operational circumstances.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported peel (coating) complaint; however, the reported physical resistance appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, 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: 8664807
• MDR Text Key: 146979009
• Report Number: 2024168-2019-04345
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 1012270-12
• Device Lot Number: 90328G2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2019
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR