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

Catalog Number	B2050-150
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Abbott vascular (av) analyzed the returned device and confirmed the reported leak in the hub.A review of the complaint handling database found no other similar incidents from this lot.Av reviewed the lot history record and there were no manufacturing nonconformities that would have contributed to this complaint.Av conducted root cause determined the most probable root cause is variability in the gluing process during manufacturing.The issue will be addressed per internal operating procedures.Av will continue to trend the performance of these devices.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, de novo lesion in the non-tortuous right superficial femoral artery (sfa).A 5.0mm x 150mm x 135cm armada 35 balloon dilatation catheter (bdc) was prepped without issue and advanced to the lesion without resistance.When attempting to inflate the balloon, the device would not hold pressure and leaking of contrast was noted to be coming from the strain relief area of the shaft that connects to the proximal hub.The partially inflated balloon was able to be deflated without difficulty and was withdrawn without resistance.There were no adverse patient effects and no occurrence of a clinically significant delay.A larger unspecified 6.0mm armada bdc was used to successfully complete dilatation.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: 6528629
• Report Number: 2024168-2017-03724
• Device Sequence Number: 1279256
• Product Code: LIT
• UDI-Device Identifier: 08717648155222
• UDI-Public: (01)08717648155222(17)180731(10)50224G1
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 04/27/2017

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: 07/31/2018
• Device Catalogue Number: B2050-150
• Device Lot Number: 50224G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1