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

Catalog Number	B1040-080
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2017
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.The device was not returned for analysis.It is likely that the rupture occurred due to interaction with lesion calcification.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.Based on the information provided, the reported difficulties appear to be due to operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a restenosis lesion in the mildly tortuous, moderately calcified, 70% stenosed, mid femoral artery.A 4.0 x 80 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced to the lesion and upon the 3rd inflation the balloon ruptured at 20 atmospheres.A new unspecified balloon catheter was used to successfully complete the procedure.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information provided.

• 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: 7108936
• Report Number: 2024168-2017-09611
• Device Sequence Number: 16433314
• Product Code: LIT
• UDI-Device Identifier: 08717648154539
• UDI-Public: 08717648154539
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2017

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: 11/30/2020
• Device Catalogue Number: B1040-080
• Device Lot Number: 70531G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 56