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

Catalog Number	B2070-080
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The reported difficult to insert through an introducer sheath was unable to be confirmed due to the condition of the device.During functional testing, fluid was observed coming out from a pinhole in the balloon.There was a vertical scratch distal to the pinhole.The investigation determined the reported/noted difficulties to insert, balloon pinhole rupture and scratch appear to be related to circumstances of the procedure.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The 7x60mm armada device referenced is being filed under separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat lesion in the right superficial femoral artery.A 7x80mm armada 35 balloon catheter was used to pre-dilate the lesion.The balloon catheter was removed and an unknown stent was implanted; however, when attempting to re-insert the balloon catheter for post-dilatation it could not be inserted in the sheath.A 7x60mm armada 35 balloon catheter was used to post-dilate the stent.The balloon catheter was removed and an attempt to insert it again for additional post-dilatation was made; however, it could not be inserted into the sheath.The procedure was successfully completed with 7x80mm non-abbott balloon catheter.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.The return device analysis noted pinhole ruptures in both of the armanda balloons.

• 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: 7293121
• Report Number: 2024168-2018-01352
• Device Sequence Number: 16462811
• Product Code: LIT
• UDI-Device Identifier: 08717648155376
• UDI-Public: 08717648155376
• 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
• Report Date (Section B): 02/23/2018

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: 03/21/2021
• Device Catalogue Number: B2070-080
• Device Lot Number: 71025G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 77