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

Catalog Number 1012268-12

Device Problems Material Rupture (1546); Stretched (1601)

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, functional and scanning electron microscopy (sem) inspection/analysis were performed on the returned device.The reported stretched shaft was confirmed.The reported balloon rupture was unable to be confirmed; however, there was a noted longitudinal tear noted in the outer member, distal to the guide wire exit notch which likely was perceived as the rupture by the account.Additionally, tears, wrinkles and bunching was noted on the 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 determined the reported complaints appears to be related to operational context.It was reported that the patient presented with severe lesions and three unspecified stents were implanted covering the affected lesions.Post-dilatation was attempted with a 1.20x12mm mini trek bdc and a 1.50x12mm mini trek bdc.In this case, it is likely that the balloon dilatation catheter (bdc) was inadvertently mishandled and interacted with the three previously implanted stents resulting in the noted damage (tears, wrinkles, bunching), reported stretching and noted longitudinal tear on the outer member, giving the impression of a ruptured balloon.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 12624026
• MDR Text Key: 276167303
• Report Number: 2024168-2021-09179
• Device Sequence Number: 1
• Product Code: LOX
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 1012268-12
• Device Lot Number: 00427G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2020
• 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