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

Model Number	SK13518
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2023).
Event or Problem Description
It was reported that during a recanalization procedure, the support catheter was allegedly kinked and unable to cross lesion.Reportedly, another support catheter was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one partial seeker crossing support catheter was returned for evaluation, remaining seeker catheter segment was not returned.Sample was noted to be bloody, break noted the sample which measured approximately 1.7cm.No other anomalies were noted to the sample.Based on the findings, the investigation is confirmed for the reported detachment as partial segment of the seeker was returned for evaluation.However, the investigation is inconclusive for the reported failure to advance issue as no functional testing can be performed due to the nature of the returned device.A definitive root cause for the reported failure to advance and detachment issues could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 01/2023), g3, h6 (method).H11: b5, h6 (result and conclusion).
Event or Problem Description
It was reported that during a recanalization procedure, the support catheter was allegedly detached and unable to cross lesion.Reportedly, another support catheter was used to complete the procedure.There was no reported patient injury.

• Brand Name: SEEKER CROSSING SUPPORT
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12244457
• Report Number: 2020394-2021-01405
• Device Sequence Number: 2871005
• Product Code: DQY
• UDI-Device Identifier: 00801741067884
• UDI-Public: (01)00801741067884
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: SK13518
• Device Catalogue Number: SK13518
• Device Lot Number: VTFN0535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/17/2021
• 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: Other
• Patient Age: 80 YR
• Patient Weight: 75