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

Model Number	B1080-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, mildly tortuous, 90% lesion in the right external iliac artery.Atherectomy was performed and an 8x40mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion and inflated one time; however, it ruptured at burst pressure.Subsequently, an 8x60mm armada 35 bdc was advanced and inflated one time to nominal pressure when the balloon ruptured and separated from the catheter in the right external iliac artery.One hour was spent trying to snare out the separated segment, however it was unsuccessful.An 8.X5cm non-abbott covered stent was implanted to embed the separated segment in the artery.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 provided, the reported material rupture appears to be due to circumstances of the procedure.It is likely that the balloon rupture occurred due to interaction with calcification.There was no report of leaks noted during preparation for use, suggesting that the balloon damage was not pre-existing.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The 8x60mm armada 35 balloon referenced is filed under separate medwatch report number.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: 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: 15499392
• Report Number: 2024168-2022-10079
• Device Sequence Number: 17438599
• Product Code: LIT
• UDI-Device Identifier: 08717648154867
• UDI-Public: 08717648154867
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2022

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 Model Number: B1080-040
• Device Catalogue Number: B1080-040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIABHAN STENT
• Patient Age: 65 YR
• Patient Sex: Male