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

Catalog Number 1012268-06

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported this was a procedure to treat a heavily calcified and heavily tortuous right coronary artery.A 12x6mm trek rx balloon delivery catheter (bdc) was inserted and advanced to the target lesion.It was noted that due to the heavy calcification, there was resistance during advancement.While inflating the bdc, it was observed it ruptured at 20 atmospheres.The bdc was removed and replaced.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.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 incidents reported from this lot.The investigation determined the reported difficulty to advance and balloon rupture appears to be related to case circumstances of the procedure.In this case, based on the reported information, it is likely that during advancement through the challenging, the balloon outer surface became compromised and/or damaged against resulting in the balloon rupture during inflation.It should be noted that instructions for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The reported ifu violation does not appear to have caused or contributed to the reported complain.It is likely that the balloon became damaged against the challenging anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no corrective action is required.

• 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: 12861710
• MDR Text Key: 281158764
• Report Number: 2024168-2021-10738
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 1012268-06
• Device Lot Number: 91204G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• 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