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

Model Number	SK13535M
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	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that during a treatment of a highly calcified lesion in sfa, the recanalization crossing support catheter allegedly broke in segments.It was further reported that a snare device was used to capture and retrieve all the segments.Reportedly, there was no further treatment.There was no reported patient injury.
Event or Problem Description
It was reported that during a treatment of a highly calcified lesion in sfa, the recanalization crossing support catheter allegedly broke in segments.It was further reported that a snare device was used to capture and retrieve all the segments.Reportedly, there was no further treatment.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: one seeker catheter was returned for evaluation.The distal end of the returned device was noted to be stretched and jagged, indicating a detachment.The returned catheter was measured and it was determined 10.7cm of the catheter was not returned for evaluation.Therefore, the investigation is confirmed for the alleged detachment.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.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• 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: 7621390
• Report Number: 2020394-2018-00927
• Device Sequence Number: 2067199
• Product Code: DQY
• UDI-Device Identifier: 00801741067891
• UDI-Public: (01)00801741067891
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/21/2018

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: SK13535M
• Device Catalogue Number: SK13535M
• Device Lot Number: VTBS0074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 76