MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number 1014265-080

Device Problems Material Rupture (1546); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.The additional armada device referenced is being filed under a separate medwatch report.

Event Description

It was reported that a 6.0x80mm armada 18 percutaneous transluminal angioplasty (pta) catheter was advanced to treat a 60% stenosed, mildly tortuous, mildly calcified, de novo lesion in the mid left superficial femoral artery (sfa).It was noted that there was some resistance during advancement due to calcification.The balloon was inflated once to approximately 7 atmospheres when it ruptured.The pta catheter was removed, and another unspecified balloon device was used to treat the target lesion.A 5.0x150mm armada 18 pta catheter was then advanced to treat a 65% stenosed, mildly tortuous, mildly calcified, de novo lesion in the distal right sfa.It was noted that there was some resistance during advancement due to calcification.The balloon was inflated once to approximately 7 atmospheres when it ruptured.The pta catheter was removed, and another non-abbott balloon device was used to treat the target lesion and the procedure concluded.There were no reported adverse patient effects, and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number (b)(4).Evaluation summary: a visual inspection was performed, and the reported balloon rupture was confirmed.The reported physical resistance was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot or relabeled lot.The investigation determined the reported balloon rupture appears to be related to circumstances of the procedure.In this case, it is likely that during advancement the balloon encountered resistance with the 60% stenosed, mildly tortuous, mildly calcified compromising and/or damaging the balloon resulting in the balloon rupture then during inflation.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: ARMADA 18 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: 8341307
• MDR Text Key: 136275844
• Report Number: 2024168-2019-01123
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 1014265-080
• Device Lot Number: 8020241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1