MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC TURNPIKE LP; CATHETER

Model Number	5639
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and no non-conformances were found.A returned product evaluation confirmed that the microcatheter's shaft had separated at a location approximately 1mm inside of the distal end of the hub's strain relief.Only the hub attached to the proximal section of the separated shaft was returned for analysis.There was no visual damage to the hub itself.The most likely root cause for the reported event is that the catheter was damaged during use.
Event or Problem Description
During a procedure, the physician found it difficult to torque the turnpike lp microcatheter and tried to retrieve the microcatheter, at which point the proximal hub separated from the microcatheter.The tip of the turnpike was not stuck when the physician tried to remove it.The proximal end of the microcatheter shaft was outside the patient's body, so the physician removed the distal shaft without using an extra device.There was no reported harm to the patient, so the hospital declined to provide patient information.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7293503
• Report Number: 2134812-2018-00009
• Device Sequence Number: 877268
• Product Code: DQY
• UDI-Device Identifier: M20656390
• UDI-Public: M20656390
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2018

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: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: 5639
• Device Lot Number: 611032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/23/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention