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

Catalog Number B1120-060

Device Problems Off-Label Use (1494); Material Rupture (1546); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.User facility medwatch.Uf/ importer reporter # (b)(4) - [(b)(4)].

Event Description

It was reported that during a left upper extremity arteriovenous graft, left subclavian vein angioplasty and stenting procedure, the balloon of a 12 x 60 mm armada 35 percutaneous transluminal angioplasty (pta) balloon catheter ruptured.The tip of the pta balloon catheter separated and the tip was successfully retrieved with a snare device via the axillary vein.There was no reported adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number (b)(4).Evaluation summary: visual analysis was performed on the returned device.The reported balloon rupture and separation was confirmed.It was reported that the armada 35 was being used to treat the left subclavian vein.It should be noted that the indication for use section listed in the armada 35 instruction for use states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.It could not be determined if using off-label contributed to the reported difficulties.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 incidents from this lot.The investigation was unable to determine a cause for the reported balloon rupture.The separation and additional treatment to remove the separated material 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 Description

Returned device analysis identified: the balloon of the 12 x 60 mm armada 35 percutaneous transluminal angioplasty (pta) balloon catheter was ruptured radially and separated.The tip was still attached to the balloon and a portion of the separated balloon was not returned.The inner and outer members were separated.The separated portions of the inner member were returned on an abbott 0.035 supra core guide wire.The account confirmed that nothing remained in the patient anatomy post procedure and the balloon separation is what they had reported initially as a tip separation.It was not known if the pta balloon catheter shaft separation occurred during the procedure.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8209890
• MDR Text Key: 131847456
• Report Number: 2024168-2019-00018
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: B1120-060
• Device Lot Number: 80621G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: .035 SUPRA CORE
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR