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

Catalog Number 1012279-15

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that before the tyvek pouch of a 4.5x15mm trek rx balloon dilatation catheter (bdc) was used it was noted to be unsealed.Because sterility was compromised the device was not used and there was no patient involvement.An unspecified balloon was used to continue the procedure.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned with the pouch having been opened.The observed cloudy appearance in the seal area of the returned devices demonstrates that the seals originally existed at some point.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.There is no evidence to indicate that a wider population of product has potentially been impacted.The performance of these devices will continue to be monitored.

Event Description

It was reported that before the tyvek pouch of a 4.5x15mm trek rx balloon dilatation catheter (bdc) was used, it was noted to be unsealed.It appeared that someone had started to open the vendor seal.Because sterility was compromised the device was not used and there was no patient involvement.An unspecified balloon was used to continue the procedure.There was no clinically significant delay in the procedure.No additional information was provided.

• 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): EL COYOL, COSTA RICA REG# 3009031392; 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: 5780818
• MDR Text Key: 49144447
• Report Number: 2024168-2016-04466
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 1012279-15
• Device Lot Number: 50211G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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