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

Catalog Number	1012448-20
Medical Device Problem Codes	Inflation Problem (1310); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
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.Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported separation was confirmed.The reported difficulty positioning the device with the guide wire and the balloon rupture could not be confirmed.The reported difficulty positioning the bdc with the guiding catheter, introducer sheath, inflation issue and difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 determined the reported difficulties appear to be related to operational context.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 left anterior descending coronary artery with moderate calcification and moderate tortuosity.A 6f sheath was placed and two unspecified guide wires and a non- abbott guide catheter extension were advanced.A 2.75 x 20 mm nc trek rx balloon dilatation catheter (bdc) was then advanced through the sheath with resistance from all other devices due to the tight fit.On attempting to inflate the balloon of the bdc to 16 atmospheres, the balloon failed to inflate.The bdc failed to hold pressure and blood was noted to be backing up into the manifold [rupture].The bdc was therefore attempted to be removed without force; however, resistance was met with the sheath on removal and a distal shaft separation occurred.The separated portion of the bdc was simply removed on the guide wire and a new 2.75 x 20 nc trek was used to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• 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: 8746349
• Report Number: 2024168-2019-05244
• Device Sequence Number: 16785815
• Product Code: LOX
• UDI-Device Identifier: 08717648151835
• UDI-Public: 08717648151835
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2019

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: 10/31/2021
• Device Catalogue Number: 1012448-20
• Device Lot Number: 81122G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 82