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	10/19/2018
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.
Event or Problem Description
It was reported that during a procedure in the right sfa with left common femoral artery access via a contralateral approach, the tip of the support catheter allegedly detached.It was further reported that the healthcare provider (hcp) retrieved the detached segment without incident.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a dhr review was not required as this lot met all release criteria.There was nothing found to indicate a manufacturing-related cause for this event.Investigation summary: one seeker was returned for evaluation.The device was returned with a detached tip, therefore, the investigation is confirmed for tip detachment.The catheter measured approximately 149.0cm from the strain relief.Therefore, the length of detached segment was approximately 1 centimeter.The root cause could not be determined based upon available information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H11:section a through f - 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 procedure in the right sfa with left common femoral artery access via a contralateral approach, the tip of the support catheter allegedly detached.It was further reported that the healthcare provider (hcp) retrieved the detached segment without incident.There was no reported patient injury.

• 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: 8087211
• Report Number: 2020394-2018-02073
• Device Sequence Number: 19227328
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: VTCW0336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 01/17/2020
• 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
• Patient Weight: 81