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

Catalog Number 1012280-15

Device Problems Collapse (1099); Difficult to Remove (1528)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A partial udi is being reported because the lot number was not provided.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficulty.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported that while unpackaging a 5.0x15mm trek rx balloon dilatation catheter (bdc), the protective sheath was difficult to remove.Upon removal the distal tip appeared to be wrinkled / crumpled.The device was not used in patient anatomy and there was no occurrence of a clinically significant delay.Another unspecified device was used to treat the patient.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: date of event.

• 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 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6602898
• MDR Text Key: 76501256
• Report Number: 2024168-2017-04629
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138782
• UDI-Public: (01)08717648138782
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

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 Catalogue Number: 1012280-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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