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

Catalog Number	B1090-040
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2017
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.The additional armada devices referenced are being filed under separate medwatch reports.Evaluation summary: visual inspection was performed on the returned device.The reported balloon rupture was confirmed.It is likely that the reported balloon rupture occurred due to interaction with the lesion site.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 revealed no other incidents.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 respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the left common iliac with moderate calcification.The superficial femoral artery (sfa) was successfully treated with a stent implant prior to treating the left common iliac.Pre-dilatation was not performed initially to treat the iliac.Resistance was felt during the advancement of the 8 x 39 mm omnilink elite stent delivery system (sds) and the sds would not cross the lesion.Pre-dilatation was performed using a 7 x 60 mm armada 35 balloon dilatation catheter (bdc).Resistance was not felt during the advancement of the bdc; however, the balloon rupture during the first inflation between 3 to 4 atmospheres.Resistance was not felt as a second 7 x 40 mm armada 35 bdc was advanced to the lesion for pre-dilatation; however, it ruptured during the first inflation between 3 to 4 atmospheres.A non-abbott bdc was then advanced to the lesion and ruptured during inflation.Pre-dilatation was successfully performed using a second non-abbott bdc which inflated without issues.The previously used ominlink elite was advance to the lesion without resistance and was successfully deployed.Post-dilatation was performed using a 9 x 40 mm armada 35 bdc.Resistance was not felt as the bdc was advanced to the lesion and it cross successfully; however, the balloon ruptured during the first inflation between 7 and 8 atmospheres.A new bdc was not required to complete the post-dilatation because it was achieved when the bdc was inflated to nominal (6 atmospheres) pressure prior to rupture.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: 6541079
• Report Number: 2024168-2017-03862
• Device Sequence Number: 1088599
• Product Code: LIT
• UDI-Device Identifier: 08717648154904
• UDI-Public: (01)08717648154904(17)200531(10)61124G1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2017

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: 05/31/2020
• Device Catalogue Number: B1090-040
• Device Lot Number: 61124G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2017
• Initial Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1