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

Catalog Number	B1040-120
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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.Na.
Event or Problem Description
It was reported that before use, there was difficulty in removing the protective sheath from a 4.0 x 120 mm armada 35 balloon catheter.However, it was replaced with an unspecified device to successfully complete the procedure.There was no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported difficulty could not be confirmed as the protective sheath was not returned.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 incidents and/or complaints.Based on the reported information and analysis of the returned device, a cause for the reported difficulty was unable to be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001.
Event or Problem Description
It was reported that before use, there was difficulty in removing the protective sheath from a 4.0 x 120 mm armada 35 balloon catheter.However, it was replaced with an unspecified device to successfully complete the procedure.There was no patient involvement.No additional information was provided.

• 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: 8837120
• Report Number: 2024168-2019-10419
• Device Sequence Number: 19430697
• Product Code: LIT
• UDI-Device Identifier: 08717648154553
• UDI-Public: 08717648154553
• 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
• Report Date (Section B): 10/10/2019

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: 04/30/2022
• Device Catalogue Number: B1040-120
• Device Lot Number: 81105G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1