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

Catalog Number 1012274-15

Device Problems Deflation Problem (1149); Material Rupture (1546); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2014

Event Type  malfunction  

Event Description

It was reported that the target lesion was located in the right coronary artery (rca) with moderate calcification.The 3.0 x 15 mm trek balloon was inflated 2 to 3 times to 14 atmospheres (atm) and the balloon ruptured at 14 atm.After the balloon was retracted from the anatomy, it was noted that the balloon did not refold correctly and was not completely deflated.Although the balloon was retracted from the anatomy partially inflated, no resistance was encountered.A 3.5 x 15 mm trek balloon was then selected for use, but was noted to be kinked prior to use and was not used on the patient.An unspecified balloon was used to complete the procedure.No adverse patient effects were reported.There was no clinically significant delay of procedure reported.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported balloon rupture and poor re-fold were confirmed.The reported deflation issue could not be replicated due to condition of the returned device.Based on visual and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances or exceptions for this lot.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.

• 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: 3852185
• MDR Text Key: 4682519
• Report Number: 2024168-2014-03615
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2014

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: 01/31/2016
• Device Catalogue Number: 1012274-15
• Device Lot Number: 40214G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 06/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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