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

Catalog Number	B1080-060
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2017
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.2017: incorrect anatomy / incorrect removal.Evaluation summary: a visual inspection was performed.The reported difficulty removing the balloon catheter from the introducer sheath was not tested due to the returned condition of the device.It should be noted that the armada 35 / (b)(6) instructions for use, states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries.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 identified no other similar incidents reported from this lot.The investigation determined that the reported difficulties appear to be related to circumstance of the procedure as the balloon was not fully deflated before removal through the introducer sheath resulting in the reported/noted inner member and balloon separation and longitudinal rupture.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 unknown lesion located in the cephalic vein.During removal, the balloon broke and had to be retrieved.The balloon was not fully deflated and when removing from the sheath, it separated.There was no reported deflation issue, the physician did not make sure it was fully deflated before trying to remove.A snare device was used to remove the separated segment.There was no adverse patient effect and no clinically significant delay.Resistance was noted during withdrawal with the introducer sheath.Device analysis revealed the balloon was separated radially, also, the inner member was separated.

• 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: 7187877
• Report Number: 2024168-2018-00341
• Device Sequence Number: 13814853
• Product Code: LIT
• UDI-Device Identifier: 08717648154874
• UDI-Public: 08717648154874
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/12/2018

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: 12/31/2020
• Device Catalogue Number: B1080-060
• Device Lot Number: 70710G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/12/2018
• 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