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

Model Number	B1070-060
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event has been estimated.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat an unspecified artery.A 7x60mm armada 35 balloon dilatation catheter ruptured at 12 atmospheres when inflated.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints related to this event.Based on the limited information provided, the investigation was unable to determine a conclusive cause for the reported balloon rupture.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported rupture was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified one other incident and/or complaint reported from this lot; however, this complaint was not related to this event.Based on the limited information provided, the investigation was unable to determine a conclusive cause for the reported balloon rupture.There is no indication of a product quality issue with respect to manufacture, design or labeling.H10 corrected to reflect device analysis performed on returned device.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10075385
• Report Number: 2024168-2020-04427
• Device Sequence Number: 11471950
• Product Code: LIT
• UDI-Device Identifier: 08717648154799
• UDI-Public: 08717648154799
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2020

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: 02/28/2023
• Device Model Number: B1070-060
• Device Catalogue Number: B1070-060
• Device Lot Number: 90921G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 07/08/2020; 07/29/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/24/2020; 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1