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

Catalog Number 1012454-12

Device Problems Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2014

Event Type  malfunction  

Event Description

Subsequent to the previously filed medwatch report, the balloon dilatation catheter (bdc) was returned with the distal shaft cut and the distal shaft (including the balloon) was not returned.Follow-up information received from the account stated that the shaft was cut post-procedure, and that the distal shaft (including the balloon) was returned, but packed separately.As the account stated that the distal shaft was returned together, but was separately packaged, it is likely that the distal shaft was inadvertently discarded during the returned goods (rg) lab inventory process.No additional information was provided.

Event Description

It was reported that the procedure was to treat a 95% stenosed, heavily calcified lesion in the moderately tortuous proximal right coronary artery (rca).A 4.0x18mm xience prime stent delivery system (sds) was advanced to the lesion and successfully deployed.The 4.50x12mm nc trek balloon dilatation catheter (bdc) was used successfully for post-dilatation of the deployed xience prime stent implant; however, upon deflation it was noted that the nc trek balloon did not re-fold correctly and resistance was encountered during the attempt to retract the nc trek bdc into the 7 f non-abbott guiding catheter.All devices (bdc, guide wire, and guiding catheter) were withdrawn as a single unit.A non-abbott bdc was successfully used to complete post-dilatation.There was no reported adverse patient sequela and no reported clinically significant delay in the procedure.There was no additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported balloon refold issue could not be confirmed because the distal segment including the balloon was not available.Due to returned device condition, the reported resistance with the guiding catheter could not be verified/confirmed.Based on the visual analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that could have contributed to the reported event.A query/review of the electronic complaint handling database revealed no other similar incidents for balloon refold issues reported from this lot or the repacked lot.Based on the information reviewed, there is no indication of a product deficiency.

Manufacturer Narrative

(b)(4).Concomitant products: guide wire: pilot 50; guide catheter: launcher; stent: 4.0x18mm xience prime.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3671066
• MDR Text Key: 4300765
• Report Number: 2024168-2014-01408
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2014

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: 06/30/2014
• Device Catalogue Number: 1012454-12
• Device Lot Number: 2072361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2014
• Initial Date FDA Received: 03/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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
• Treatment: CONCOMITANT MEDICAL DEVICES