MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SEEKER SUPPORT CATHETER

Model Number	SK15035M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records were provided to the manufacturer.An image was provided.The lot number for the device was provided.The device history records and image are currently under review.The sample was not returned to the manufacturer for inspection/evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during a treatment of a highly calcified lesion in sfa, the recanalization crossing support catheter was allegedly broke in segments.It was further reported that a snare device was used to capture and retrieve all the detached segments.Reportedly, a dabr laser and a balloon were used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review:the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary:the device was not returned for evaluation; however, three digital photos were provided for review.From the provided photos, two segments of seeker catheter can be identified as separated from the main device.One of the separated segments contains the distal tip and marker band of the device.Therefore, based on the returned photos, the investigation can be confirmed for the detachment of the two identified segments in the photos.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review:the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that during a treatment of a highly calcified lesion in sfa, the recanalization crossing support catheter was allegedly broke in segments.It was further reported that a snare device was used to capture and retrieve all the detached segments.Reportedly, a dabr laser and a balloon were used to complete the procedure.There was no reported patient injury.

• Brand Name: SEEKER SUPPORT CATHETER
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7603995
• Report Number: 2020394-2018-00879
• Device Sequence Number: 1897777
• Product Code: DQY
• UDI-Device Identifier: 00801741067921
• UDI-Public: (01)00801741067921
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K103367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2018

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: SK15035M
• Device Catalogue Number: SK15035M
• Device Lot Number: VTCR0184
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 92