MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Catalog Number	1012451-08
Medical Device Problem Codes	Inflation Problem (1310); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Exemption number e2019001.Evaluation summary: visual and functional inspections were performed on the returned device.The reported inflation issue was not confirmed.The inner and outer member were stretched proximal to the proximal seal, possibly from inadvertent mishandling; however, it is unknown when these damages occurred.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported inflation issue.However, factors that may contribute to difficulty inflating may include, but are not limited to, damage to the inflation lumen, poor connection with the inflation device, patient anatomical morphology and patient disease state.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 heavily calcified lesion in the mid left anterior descending (lad) coronary artery.The 3.5x8 mm nc trek balloon dilatation catheter (bdc) completely failed to inflate inside the anatomy but outside the anatomy was able to be inflated with no issues.A new, same size nc trek bdc was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.Return device analysis identified a stretched shaft just proximal to the balloon seal.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 9192932
• Report Number: 2024168-2019-05579
• Device Sequence Number: 19747888
• Product Code: LOX
• UDI-Device Identifier: 08717648151965
• UDI-Public: 08717648151965
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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: 07/31/2021
• Device Catalogue Number: 1012451-08
• Device Lot Number: 80827G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2019
• Initial Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 75