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

Model Number	SK9035M
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	03/05/2018
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 return of the device is pending.The results of the anticipated device evaluation will be provided upon completion of the event investigation.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 two segments.No further treatment was provided.There was no reported patient injury.
Additional Manufacturer Narrative
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.One seeker catheter was returned in two segments for evaluations.The first segment measured 26.5cm in length and contained the distal tip of the device.The second segment was the remaining length of the catheter device.The break on the catheter was examined closer under magnification (20x) and the break was not clean with evidence of stretching and ridges.The condition of the break is indicative of excessive force used on the catheter.Therefore, the investigation can be confirmed for the alleged detachment of the device.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 removal of the support catheter from the patient, the catheter allegedly detached into two segments.No further treatment was provided.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: 7384010
• Report Number: 2020394-2018-00303
• Device Sequence Number: 1392904
• Product Code: DQY
• UDI-Device Identifier: 00801741067952
• UDI-Public: (01)00801741067952
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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: SK9035M
• Device Catalogue Number: SK9035M
• Device Lot Number: VTBU0507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR