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

Catalog Number 1012455-15

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2014

Event Type  malfunction  

Event Description

It was reported that using a brachial artery access approach during a procedure of the eccentric, 70% restenosed, non-tortuous, proximal left anterior descending (lad) artery predilatation with a 5.0 x 10 mm non-abbott balloon dilatation catheter (bdc) was completed at 6 atmosphere (atm) for 6 seconds and inflated again.The bdc was removed and the 4.0 x 18 mm xience prime stent was deployed at 14 atm for 30 seconds.It was noted that post-dilatation was completed using a 5.0 x 15 mm nc trek bdc at 12 atm and 16 atm but after deflation the bdc met resistance while attempting to be removed.The bdc was inflated and deflated twice and was removed with resistance.Although the indeflator was not on negative pressure, after removal from the anatomy the balloon was noted to be winged.Additionally, the bdc shaft was noted to have separated during removal.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.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 for evaluation.The reported separation and winged balloon was confirmed.The reported difficult to remove the balloon catheter was not confirmed due to the condition of the returned device.Based on 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 would have contributed to this complaint.A query of the 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: 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: 4093375
• MDR Text Key: 4714534
• Report Number: 2024168-2014-05956
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K110134
• 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: 08/22/2014

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: 05/31/2016
• Device Catalogue Number: 1012455-15
• Device Lot Number: 40602G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 09/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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: STENT: XIENCE PRIME 4.0X18MM
• Patient Age: 75 YR