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

Catalog Number	B2060-060
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2018
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.The incident information was reviewed; however, the product was not returned to abbott vascular for analysis.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 was unable to determine a conclusive cause for the reported balloon rupture.The reported difficulty removing the device causing the balloon separation appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that procedure was to treat a lesion in a heavily calcified, 80% stenosed, right superficial femoral artery.A 6 x 60 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced to the lesion without resistance.The balloon was inflated to 10 atmospheres, but on the second inflation the balloon ruptured before reaching nominal pressure.During removal of the pta catheter from the anatomy, the balloon caught on the edge of the unspecified 6f short introducer sheath and a portion of the balloon separated from the shaft.The pta catheter was removed from the anatomy.The 6f short introducer sheath was removed from the anatomy and replaced with a longer introducer sheath in an unsuccessful attempt to capture the balloon fragment.A cut down procedure was performed to remove the balloon fragment from the anatomy.The procedure was completed with the successful deployment of an unspecified stent implant.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: 7459268
• Report Number: 2024168-2018-03049
• Device Sequence Number: 1093150
• Product Code: LIT
• UDI-Device Identifier: 08717648155277
• UDI-Public: 08717648155277
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 04/25/2018

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: 04/30/2021
• Device Catalogue Number: B2060-060
• Device Lot Number: 71110G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH: 6F SHORT SHEATH
• Outcome Attributed to Adverse Event: Required Intervention