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

Model Number	1012453-20
Medical Device Problem Codes	Inflation Problem (1310); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported inflation issue was not confirmed.However, the analysis identified the inner and outer member was stretched and bunched distal to the mid lap seal.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.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
Event or Problem Description
It was reported that the procedure was to treat a de novo, moderately calcified, mildly tortuous lesion in the left anterior descending (lad) artery.The 4.0x20 mm nc trek balloon dilatation catheter (bdc) was able to hold pressure but could only partially inflate inside the previously implanted stent.There was no difficulty in removing the stylet or protective sheath.Another nc trek bdc was used to successfully complete the procedure.There were no reported adverse patient effects and there was no clinically significant delay in the procedure.Returned device analysis identified a stretched inner/outer member.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12378821
• Report Number: 2024168-2021-07597
• Device Sequence Number: 3938549
• Product Code: LOX
• UDI-Device Identifier: 08717648152085
• UDI-Public: 08717648152085
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 1012453-20
• Device Catalogue Number: 1012453-20
• Device Lot Number: 90226G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 78