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

Catalog Number 1012455-12

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

Patient Problem Angina (1710)

Event Date 11/06/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Correction: the device was initially reported as returning, but has now been reported as not returning because it was discarded at the account.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.Angina is listed in the instructions for use (ifu), in the adverse effects section as a known adverse event.Although a conclusive cause for the reported patient effect and the relationship to the device, if any, cannot be determined, there is no indication of a product quality deficiency with respect to manufacture, design, or labeling.Based on the information reviewed, manufacturing records and similar incident analysis, there is no indication of a product quality deficiency.

Event Description

It was reported that the procedure was to treat a lesion in the proximal right coronary artery with heavy tortuosity and moderate calcification.The 5.0 x 12 mm nc trek balloon catheter was un-packaged for use.Resistance was noted during removal of the protective sheath.The nc trek was advanced without issue to the lesion and inflated two times to 14 atmospheres (atm) and 18 atm; however, it was observed that the balloon was unable to be refolded after inflation.During removal, resistance was noted with the anatomy; therefore, the physician withdrew the balloon with the guide wire, as a signal unit.The patient felt chest pain during removal of the trek, but no medication or treatment was needed.The final outcome was satisfactory and the procedure was completed successfully.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

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 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): EL COYOL, COSTA RICA REG# 3009031392; 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: 4287496
• MDR Text Key: 12664037
• Report Number: 2024168-2014-07829
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/06/2014

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: 01/31/2017
• Device Catalogue Number: 1012455-12
• Device Lot Number: BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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: 56 YR
• Patient Weight: 71