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	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 treatment of a heavily calcified lesion in the right sfa the tip of the support catheter allegedly detached and migrated to the profunda femoris artery.The health care provider (hcp) attempted to snare the detached tip but was unsuccessful.It was further reported that the hcp decided to leave the detached tip in situ as there was no potential health hazard to the patient.The procedure was concluded, and no further treatment was provided.There was no reported patient injury.
Event or Problem Description
It was reported that during treatment of a heavily calcified lesion in the right sfa the tip of the support catheter allegedly detached and migrated to the profunda femoris artery.The health care provider (hcp) attempted to snare the detached tip but was unsuccessful.It was further reported that the hcp decided to leave the detached tip in situ as there was no potential health hazard to the patient.The procedure was concluded, and no further treatment was provided.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 returned.The investigation is confirmed for tip detachment as the 1.8cm of the catheter distal end is detached and not returned.Per the reported event the lesion was heavily calcified and the catheter was not being used for a recanalization procedure, this may have contributed to the event.However, 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 current ifu (instructions for use) states: warnings: while retracting the catheter, if resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or catheter separation.Precautions: if resistance is felt during post procedure withdrawal of the catheter, it is recommended to remove the catheter, introducer sheath and guidewire (as necessary) as a single unit.

• Brand Name: SEEKER
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7356162
• Report Number: 2020394-2018-00261
• Device Sequence Number: 16533120
• Product Code: DQY
• UDI-Device Identifier: 00801741067921
• UDI-Public: (01)00801741067921
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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 Expiration Date: 01/12/2020
• Device Model Number: SK15035M
• Device Catalogue Number: SK15035M
• Device Lot Number: VTCN0434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR