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

Model Number	SK15014
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/29/2017
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 return of the device is pending.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 removal of the support catheter from the patient, the catheter allegedly detached into several segments.It was further reported that a snare device was used to capture and retrieve all but one of the detached segments.There was no plan to retrieve the detached segment.Patient was reported as asymptomatic.
Additional Manufacturer Narrative
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The 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 for this lot number and issue to date.Investigation summary: the device was returned.The investigation is confirmed for catheter detachment as the device was returned in 4 segments.It is unknown if procedural issues or patient issues contributed to the reported event.Based on the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.Do not continue to use the catheter if the shaft has been kinked.
Event or Problem Description
It was reported that during removal of the support catheter from the patient, the catheter allegedly detached into several segments.It was further reported that a snare device was used to capture and retrieve all but one of the detached segments.There was no plan to retrieve the detached segment.Patient was reported as asymptomatic.

• 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: 7226758
• Report Number: 2020394-2018-00031
• Device Sequence Number: 984043
• Product Code: DQY
• UDI-Device Identifier: 00801741067907
• UDI-Public: (01)00801741067907
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2019
• Device Model Number: SK15014
• Device Catalogue Number: SK15014
• Device Lot Number: VTBT0683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 66