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

Catalog Number 1012454-15

Device Problems Deflation Problem (1149); Folded (2630)

Patient Problem No Patient Involvement (2645)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The other nc trek device is filed under a separate medwatch manufacturer report reference number.

Event Description

It was reported that the procedure was to treat a lesion located in the right renal artery that was non-calcified and non-tortuous.The nc trek rx 4.5 x 15 mm balloon dilatation catheter (bdc) was being used for post-dilatation and was inflated one time to 14 atmospheres.Negative was held for 5 seconds but the balloon would only partially deflate and did not re-wrap properly (winged out).The nc trek bdc was able to be removed partially inflated with the sheath and the patient had a good outcome.There was no clinically significant delay reported.Another nc trek 4.5 x 15 mm balloon dilatation catheter was then tested outside the patient with the same issue as reported with the first device.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual, dimensional and functional inspections were performed on the returned device.The reported folded (winged balloon) was confirmed; however, the reported deflation issue could not be 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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported complaints.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
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6757047
• MDR Text Key: 81679217
• Report Number: 2024168-2017-06290
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

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: 12/31/2019
• Device Catalogue Number: 1012454-15
• Device Lot Number: 70112G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 08/01/2017
• Supplement Dates Manufacturer Received: 08/29/2017
• Supplement Dates FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR