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

Catalog Number 1012273-12

Device Problems Deflation Problem (1149); Difficult To Position (1467); Difficult to Remove (1528); Physical Resistance (2578); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2014

Event Type  malfunction  

Event Description

It was reported that during pre-dilatation, resistance and balloon twisting was felt during advancement and positioning of the 2.75x12mm trek rx balloon dilatation catheter (bdc).After inflation at 12 atmospheres, negative pressure was applied and the balloon was difficult to deflate, but was able to deflate completely.Resistance was met during retraction and the bdc was forcefully pulled into the guiding catheter and removed from the patient anatomy.After removing the bdc from the patient anatomy, the balloon was noted to have a bad refold.Another device was not required to continue the procedure.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.

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/review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the information reviewed, there is no indication of a product deficiency.

• Brand Name: 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: 3958588
• MDR Text Key: 15122231
• Report Number: 2024168-2014-04810
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2014

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: 04/30/2016
• Device Catalogue Number: 1012273-12
• Device Lot Number: 40507G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 07/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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
• Treatment: GUIDE CATH: LAUNCHER 6F EBU 3.5