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

Model Number	SK6535M
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a recanalization procedure, the device allegedly had difficulties in advancement and removal issue.It was further reported that the end of the device detached and migrated into the artery.The detached end was removed by undergoing conventional surgery through common femoral to recover the extremity.The current status of the patient is unknown.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 04/2023).
Event or Problem Description
It was reported that during a recanalization procedure, the device allegedly had difficulties in advancement and removal issue.It was further reported that the end of the device detached and migrated into the artery.The detached end was removed by undergoing conventional surgery through common femoral to recover the extremity.The current status of the patient is unknown.
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 seeker crossing support catheter was returned for evaluation.The sample was returned in two segments with a circumferential break.Segment 1 consists of the distal tip of the catheter and segment 2 consists of the remaining catheter which measures 62.5cm in length from the strain relief.No functional testing performed due to the condition of the returned sample.Although the sample was returned one electronic photo was received and reviewed.The photo shows the distal tip of the catheter.Detached catheter segment can be noted.Therefore, based on the findings, the reported detachment issue can be confirmed.However, the investigation is inconclusive for the reported difficult to advance and difficult to remove issues due to the condition of the returned device and no functional testing can be performed.A definitive root cause for the reported detachment, difficult to advance and difficult to remove 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 (expiration date: 04/2023).H11:section a through f - the information provided by bd 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 bd.

• Brand Name: SEEKER
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13754837
• Report Number: 2020394-2022-00158
• Device Sequence Number: 14695248
• Product Code: DQY
• UDI-Device Identifier: 00801741067938
• UDI-Public: (01)00801741067938
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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 Model Number: SK6535M
• Device Catalogue Number: SK6535M
• Device Lot Number: VTFR0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown