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

Model Number	SK9035M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
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.The investigation of the reported event is currently underway.(expiry date: 03/2022).
Event or Problem Description
It was reported that prior to a angioplasty procedure.The device allegedly broken.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation; therefore, the investigation is inconclusive for the alleged break issue.The root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: (expiry date: 03/2022).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.H3 other text : device not returned.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the catheter was allegedly broken into two parts.There was no patient contact.

• Brand Name: SEEKER
• Common Device Name: CROSSING SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10770245
• Report Number: 2020394-2020-20307
• Device Sequence Number: 19855435
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: SK9035M
• Device Catalogue Number: SK9035M
• Device Lot Number: VTEQ0221
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 02/08/2021
• 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