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

Catalog Number	B1050-080
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2017
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.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.The investigation determined that the reported inflation issue appears to be related to circumstances of the procedure.Based on the information reviewed, 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 during a procedure of the chronic totally occluded, heavily calcified, mid popliteal artery, the armada 35 balloon dilatation catheter (bdc) could not dilate the vessel after two inflation attempts to rated burst pressure (rbp).The balloon did not appear fully inflated and wasting was noted on angiography.The device was removed and a non-abbott bdc was used in the procedure.There was no reported adverse patient sequela or a clinically significant delay in the procedure.No additional information was 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: 6880197
• Report Number: 2024168-2017-07618
• Device Sequence Number: 801269
• Product Code: LIT
• UDI-Device Identifier: 08717648154621
• UDI-Public: 08717648154621
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

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: 11/30/2018
• Device Catalogue Number: B1050-080
• Device Lot Number: 50605G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1