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

Model Number	B1100-060
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual and dimensional analysis was performed on the returned device.The reported balloon rupture and separation was confirmed.The difficulty removing was not tested due to the condition of the device.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 from this lot.The investigation determined that the reported difficulties and subsequent patient effects was due to case circumstances.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 patient underwent a procedure to treat a target lesion in a venous fistula in the right upper extremity.The 10.0 x 60 mm armada 35 dilatation catheter was advanced to the target lesion and the balloon was inflated; however, the balloon ruptured at 18 atmospheres.The device was removed, but met resistance with the introducer sheath and the balloon separated upon removal.A segment of the balloon remained in the anatomy.Attempts were made to remove the separated segment, using a snare device, but the balloon segment remains in the anatomy.There are no plans to remove the separated segment.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Above rated balloon pressure.The rated burst pressure (rbp) indicated on the product label is 11 atmospheres (atm).The armada 35 instruction for use states: do not exceed the rated burst pressure.Inflating the balloon higher than the rated burst pressure can damage the balloon or catheter or overdistend the selected artery.The balloon rupture likely occurred due to exceeding the rbp.Additionally, the difficulty removing and separation likely occurred when the ruptured balloon material caught on the introducer sheath during removal.The investigation determined that the reported difficulties and subsequent patient effects were due to case circumstances.

• 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: 6684857
• Report Number: 2024168-2017-05625
• Device Sequence Number: 19272675
• Product Code: LIT
• UDI-Device Identifier: 08717648154959
• UDI-Public: (01)08717648154959(17)200531(10)61206G1
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 07/18/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: B1100-060
• Device Catalogue Number: B1100-060
• Device Lot Number: 61206G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2017
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/03/2017
• Supplement Report FDA Received Date: 07/18/2017
• 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