MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012274-15

Device Problems Inflation Problem (1310); Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

Visual inspection was performed on the returned device which identified a tear in the outer member and a separation in the hypotube.The reported inflation issue could not be replicated in a testing environment due to the condition of the returned device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported inflation issue.In this case, it is possible that the separation and kink were due to inadvertent mishandling of the device during advancement and/or packaging for return of the device to abbott vascular; however, since limited information was provided, a conclusive cause cannot be determined.There were multiple kinks sporadically in the inner and outer member proximal to the distal tip and multiple kinks and bends in the entire length of the hypotube likely due to handling during packaging for return of the device to abbott vascular.Return device analysis noted a tear in the outer member, proximal to the proximal balloon seal.In this case, it is possible that the the balloon dilatation catheter was inadvertently backloaded onto the guide wire at an angle resulting in the noted tear and subsequently the reported inflation issue, however, since limited information was provided, a conclusive cause cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.

Event Description

It was reported that a 3x15mm trek balloon dilatation catheter (bdc) was advanced, and the balloon failed to inflate.An unspecified balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Returned device analysis identified a tear in the outer member and a separation in the hypotube.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11508156
• MDR Text Key: 243349439
• Report Number: 2024168-2021-02112
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138430
• UDI-Public: 08717648138430
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 1012274-15
• Device Catalogue Number: 1012274-15
• Device Lot Number: 80706G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2018
• 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