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

Catalog Number	1012452-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2017
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.Concomitant medical products: guide wire: sion blue, sion; guide catheter: guideliner; optical frequency domain imaging (ofdi).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 determined the reported difficulties 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 to treat a mildly tortuous, moderately calcified, eccentric, de novo, 90% stenosed lesion in the mid right coronary artery.After pre-dilatation with a non-abbott 2.5 x 10 mm balloon catheter the lesion was observed by optical frequency domain imaging (ofdi).Additional dilatation was performed with the nc trek 3.75 x 15 mm; however, the balloon ruptured during the third inflation at 18 atmospheres.There was resistance with the anatomy during advancement to the target lesion but there was no resistance noted during removal from the anatomy.A non-abbott 4.0 x 32 mm stent was deployed and the procedure was completed after post-dilatation with a non-abbott 4.0 x 15 mm balloon catheter.The device was prepared outside of the patient anatomy, the balloon was soaked in saline prior to use of the device and there was no resistance noted during the removal of the protective sheath.There were no adverse patient effects reported 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: 6554177
• Report Number: 2024168-2017-04012
• Device Sequence Number: 97349
• Product Code: LOX
• UDI-Device Identifier: 08717648152030
• UDI-Public: (01)08717648152030(17)170930(10)41009G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2017

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: 09/30/2017
• Device Catalogue Number: 1012452-15
• Device Lot Number: 41009G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/09/2017
• 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: 73