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

Model Number	SK13514
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported information, the device is pending return to bd for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model sk13514 seeker crossing support catheter allegedly experienced a break and tip detachment.This information was received from * one source.The malfunction involved a patient with no known impact to the patient.Patient age, weight, and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model sk13514 seeker crossing support catheter allegedly experienced a break and tip detachment.This information was received from one source.The malfunction involved a patient with no known impact to the patient.Patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the device was not returned to bd for evaluation.The investigation is inconclusive for break as the device was not returned.Based on the information provided, the definitive root cause is unknown.The device is labeled for single use.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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model sk13514 seeker crossing support catheter allegedly experienced detachment of device or device component.This information was received from one source.This event did not involve a patient as there was no patient contact.Patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation, therefore, the investigation is inconclusive for detachment of device or device component.As no objective evidence has been provided to confirm any alleged deficiency with the device.This malfunction was reassesses and trending device code (1069 - break) has been removed.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H11: b5, h6 (patient code and device code 1069 - has been removed).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: SEEKER CROSSING SUPPORT CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8783027
• Report Number: 2020394-2019-01467
• Device Sequence Number: 11266225
• Product Code: DQY
• UDI-Device Identifier: 00801741067877
• UDI-Public: (01)00801741067877
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2020

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: No Information
• Device Model Number: SK13514
• Device Catalogue Number: SK13514
• Device Lot Number: VTCV0446
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 03/30/2020
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 10/10/2019; 04/03/2020
• Patient Sequence Number: 1