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

Catalog Number	1012269-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2016
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.The investigation determined the reported difficulty appears to be related to circumstances of the procedure.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.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that prior to the procedure to treat a concentric, heavily calcified, 90% stenosed, 3.0mm diameter x 20mm-long lesion in the moderately tortuous mid left anterior descending (lad) coronary artery, a 1.5x8mm mini trek rx balloon dilatation catheter (bdc) was soaked in saline and prepped via air aspiration outside of the anatomy.No resistance was felt when removing the protective balloon sheath.The 1.5x8mm mini trek rx bdc was then advanced across the target lesion without resistance to perform pre-dilatation.The mini trek bdc was inflated once to 8 atmospheres (atm) without issue.During the second inflation, the balloon ruptured at 10 atm after 15 seconds.The rx mini trek bdc was withdrawn without resistance.An unspecified 2.0mm balloon catheter was used to complete pre-dilatation, followed by implantation of an unspecified stent, successfully completing the procedure.There were no adverse patient effects and no occurrence of a clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MINI 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: 5851923
• Report Number: 2024168-2016-05212
• Device Sequence Number: 1356897
• Product Code: LOX
• UDI-Device Identifier: 08717648138089
• UDI-Public: (01)08717648138089(17)180630(10)50716G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2016

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: 06/30/2018
• Device Catalogue Number: 1012269-08
• Device Lot Number: 50716G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2016
• Initial Report FDA Received Date: 08/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1