MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B1080-020
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2017
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: radifocus.Guide catheter: terumo.The device was not returned for evaluation.There was no report of any leaks noted during preparation for use, suggesting that the balloon was not damaged prior to the procedure.Since it was reported that the patients anatomical conditions were mildly calcified and stenosed, it is likely that the patients anatomical conditions interacted with the balloon causing damage to the balloon which contributed to the reported material rupture as the balloon was being inflated.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 incidents reported from this lot.The investigation determined the reported difficulties to be related to the patient anatomical conditions.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 the procedure was to treat a de novo concentric lesion in the iliac with no tortuosity and mild calcification that was 90% stenosed.Resistance was not felt during advancement of an 8.0 mm x 20 mm/80 cm armada 35 balloon dilatation catheter (bdc) to the lesion and it crossed successfully; however, the balloon ruptured during the first inflation at 10 atmospheres, held for 30 seconds.The device was replaced with a non-abbott bdc to complete the procedure successfully.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6330815
• Report Number: 2024168-2017-01186
• Device Sequence Number: 16523556
• Product Code: LIT
• UDI-Device Identifier: 08717648154850
• UDI-Public: (01)08717648154850(17)190831(10)60315G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111899
• 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): 02/14/2017

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: 08/31/2019
• Device Catalogue Number: B1080-020
• Device Lot Number: 60315G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Initial Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1