MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number B1100-040

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was not returned for evaluation.In this particular case, the lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.Based on the information reviewed, the reported event appears to be related to circumstances of the procedure.It is likely that the rupture occurred due to interaction with lesion calcification which is described as heavily calcified.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional armada device referenced is being filed under separate medwatch report number.

Event Description

It was reported that the procedure was performed to treat a heavily calcified, non-tortuous cephalic arch.The 10x40mm armada 35 balloon ruptured at 10 atmospheres on the first inflation.A new same balloon was used and it ruptured at 12 atmospheres on the first inflation.A new non-abbott high pressure nc balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9433696
• MDR Text Key: 177778367
• Report Number: 2024168-2019-14260
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154942
• UDI-Public: 08717648154942
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B1100-040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR