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

Model Number 1012270-15

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 11/06/2021

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a moderately tortuous, moderately calcified left circumflex artery.A 2x15mm mini trek balloon was inflated three times at 10 atmospheres but didn't inflate completely (only partially inflated).It was confirmed that the balloon held pressure but just couldn't inflate completely.A trek 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.Device analysis of the returned device noted 'the balloon inflated when pressurized but did not maintain pressure as fluid leaked at the distal tip.The proximal balloon marker band, including the inner member, was noted to be torn diagonally.The inner member tearing was not visible under the marker band.'.

Manufacturer Narrative

Visual, functional and scanning electron microscopy (sem) inspections/analysis were performed on the returned device and identified a diagonal tear on the proximal balloon marker band, including the inner member.The reported inflation issue was confirmed.The sem analysis determined the sample failure may possibly be attributed to exposure conditions and/or material/processing discrepancies.A review of the lot history record identified one 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 a potential product quality issue based on the noted diagonal tear on the proximal balloon marker band, including the inner member and the confirmed inflation issue during return analysis.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 13716176
• MDR Text Key: 289317096
• Report Number: 2024168-2022-02440
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138157
• UDI-Public: 08717648138157
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 03/09/2022

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: 05/31/2023
• Device Model Number: 1012270-15
• Device Catalogue Number: 1012270-15
• Device Lot Number: 00604G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2020
• 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
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 101 KG