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

Catalog Number	1012452-12
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.Exemption number e2019001 - permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the non-tortuous, non-calcified, 90% stenosed mid left anterior descending coronary artery.Before use, a 3.75 x 12 mm nc trek balloon dilatation catheter (bdc) was inflated once at six atmospheres.Negative was held for 60 seconds to deflate the balloon, but the bdc completely failed to deflate even after several attempts.The device was not used and there was no patient involvement.A same sized unspecified bdc was used to successfully complete the procedure.The patient's final outcome is satisfactory.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Internal file number: (b)(4).Visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue was confirmed.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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported deflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 8771913
• Report Number: 2024168-2019-05456
• Device Sequence Number: 11381009
• Product Code: LOX
• UDI-Device Identifier: 08717648152023
• UDI-Public: 08717648152023
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 09/12/2019

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: 08/31/2021
• Device Catalogue Number: 1012452-12
• Device Lot Number: 80911G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1