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

Catalog Number	B2060-100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat a de novo eccentric lesion in the common iliac artery with mild tortuosity and moderate calcification that was 90% stenosed.Resistance was not felt during advancement of the 6.0 x 100 mm armada 35 balloon dilatation catheter (bdc) through the lesion and it crossed successfully for pre-dilatation.The balloon ruptured during the first inflation at 6 atmospheres held for 10 seconds.A replacement bdc was used for pre-dilatation and the procedure was successfully completed after a non-abbott stent was implanted.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.
Additional Manufacturer Narrative
Internal file number - (b)(4).Evaluation summary: visual inspections and scanning electron microscopy were performed on the returned device.The reported balloon rupture was confirmed.As there was no report of any leaks noted during preparation for use, this may suggest that the balloon was not damaged prior to the procedure.The investigation was unable to determine a conclusive cause for the reported balloon rupture.A review of the lot history record identified no manufacturing noncomformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no 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.

• 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: 6194498
• Report Number: 2024168-2016-09106
• Device Sequence Number: 16408265
• Product Code: LIT
• UDI-Device Identifier: 08717648155291
• UDI-Public: (01)08717648155291(17)170228(10)30920G1
• 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,Followup
• Report Date (Section B): 01/12/2017

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: 02/28/2017
• Device Catalogue Number: B2060-100
• Device Lot Number: 30920G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: RADIFOCUS