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

Catalog Number	1012276-25
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
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 was not returned for evaluation.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 from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the separation, difficulty removing the device from the anatomy and guiding catheter appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mid right coronary artery.A 3.5x25mm trek rx balloon dilatation catheter (bdc) was prepared per the instructions for use with a contrast mix of 50/50.The bdc was used for pre-dilatation and inflated three times at 12 atmospheres for 12 seconds.The balloon would not deflate completely and was removed partially inflated.Resistance with the anatomy and guiding catheter was felt during removal.The bdc, guide wire, and guide catheter all had to be removed together; however, during this the shaft of the bdc broke inside the guiding catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: 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: 8363570
• Report Number: 2024168-2019-01366
• Device Sequence Number: 1994963
• Product Code: LOX
• UDI-Device Identifier: 08717648138591
• UDI-Public: 08717648138591
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: 07/31/2019
• Device Catalogue Number: 1012276-25
• Device Lot Number: 60818G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 99