MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER

Model Number 1012269-12

Device Problems Break (1069); Stretched (1601); Failure to Advance (2524); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional mini trek device referenced is filed under separate medwatch report number.

Event Description

It was reported that the procedure was to treat a 70% stenosed lesion in the right coronary artery (rca).The patient presented with severe lesions and three unspecified stents were implanted covering the affected lesions.Post-dilatation was initiated and a 1.20x12mm mini trek balloon dilatation catheter (bdc) was advanced to the lesion through the stent struts, but the distal segment of the balloon ruptured at unspecified atmospheres (atm) and was removed, at which time the balloon catheter shaft became elongated.A 1.50x12mm mini trek bdc was then advanced but could not reach the target lesion and the distal segment of the catheter ruptured (broke) and became elongated upon removal from the anatomy.A third mini trek bdc was used to dilatate the lesion and successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported stretched shaft and tears were confirmed.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported complaint appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: medical device problem code 1069 - removed.

• Brand Name: MINI 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: 12624301
• MDR Text Key: 276189429
• Report Number: 2024168-2021-09184
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138096
• UDI-Public: 08717648138096
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 1012269-12
• Device Catalogue Number: 1012269-12
• Device Lot Number: 00123G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• 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