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

Catalog Number	B2060-080
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2017
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 other two armada 35 devices are filed under separate medwatch report numbers.Evaluation summary: visual inspections were performed on the returned device.The reported balloon rupture was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported balloon rupture appears to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat an 80% stenosis in a heavily calcified superficial femoral artery (sfa) and a 90% stenosis in a heavily calcified common iliac artery.A 6 x 80 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was selected for pre-dilatation of the lesion in the sfa.The pta catheter was advanced to the lesion and when inflated to 10 atmospheres (atm) the balloon ruptured.A new 7 x 80 mm armada 35 pta catheter was used to complete the pre-dilatation and an unspecified stent implant was successfully deployed.Following deployment of an unspecified stent implant in the common iliac artery, a 10 x 20 mm armada 35 pta catheter was selected for post- dilatation.When inflated to 13 atm the balloon ruptured and was replaced with a 12 x 20 mm armada 35 pta catheter.When inflated to 10 atm the balloon ruptured.As there was sufficient wall apposition additional post-dilatation was not necessary.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.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: 6846255
• Report Number: 2024168-2017-07307
• Device Sequence Number: 18843314
• Product Code: LIT
• UDI-Device Identifier: 08717648155284
• UDI-Public: 08717648155284
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/06/2017

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: 10/31/2020
• Device Catalogue Number: B2060-080
• Device Lot Number: 70518G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1