MAUDE Adverse Event Report: MEDRON, LLC SEEKER CORSSING SUPPORT CATHETER; SEEKER CATHETER ASSEMBLY, PRODUCT CODE: DQY

Model Number 0930-002

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Medron is a contract manufacture and does not own the design of the device and does not sell the device to end users.The seeker product is provided from medron to bd in bulk non-sterile packaging for further processing by bd.When a failure occurs, bd request a manufacturing review from medron.Medron reviews the device history records for the lot numbers provided and summarizes the assessment for bd.In addition to the manufacturing review, medron requests notification from bd if the event is reportable.In this instance, the event was reportable per bd and a mdr is submitted by medron.(b)(4).

Event Description

It was reported that during a treatment of a highly calcified lesion in sfa, the recanalization crossing support catheter was broke in segments.It was further reported that a snare device was used to capture and retrieve all the segments.Reportedly, a dabr laser and a balloon were used to complete the procedure.

• Brand Name: SEEKER CORSSING SUPPORT CATHETER
• Type of Device: SEEKER CATHETER ASSEMBLY, PRODUCT CODE: DQY
• Manufacturer (Section D): MEDRON, LLC; 1518 s gladiola street; salt lake city 84104
• Manufacturer (Section G): MEDRON, LLC; 1518 s gladiola street; salt lake city 84104
• Manufacturer Contact: david kujawa ; 1518 s gladiola street; salt lake city 84104 ; 8019743010
• MDR Report Key: 7639967
• MDR Text Key: 112422019
• Report Number: 1722746-2018-00008
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0930-002
• Device Lot Number: 20180365
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2018
• Type of Device Usage: N
• Patient Sequence Number: 1