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

Catalog Number	B2060-080
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual and dimensional analysis was performed on the returned device.The reported deflation issue was not able to be confirmed due to the balloon being punctured.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 was unable to determine a cause for the reported difficulties.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 proximal right superficial femoral artery with a 99% subtotal occlusion in the proximal right superficial femoral artery.A 5.0x100mm self expanding stent was implanted.A 6.0x80 mm armada 35 was inflated one time to nominal pressure to post dilate.After the first inflation, the armada was unable to be deflated.After multiple attempts were made to deflate the armada 35, it was inflated to rated burst pressure, but that did not resolve the deflation issue.With ultrasound guidance, a needle was inserted and successfully punctured the armada 35 balloon.The deflated armada 35 was removed from the anatomy.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information 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: 7918957
• Report Number: 2024168-2018-07505
• Device Sequence Number: 1346571
• Product Code: LIT
• UDI-Device Identifier: 08717648155284
• UDI-Public: 08717648155284
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: B2060-080
• Device Lot Number: 70209G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention