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

Model Number 5640

Device Problem Material Fragmentation (1261)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

There was no product returned for this complaint.No returned product evaluation could be completed.The lot number reported was incorrect, therefore, no record review could be completed.Based on the lack of information received we cannot determine a root cause.A follow-up report will be submitted if information and / or product is returned for investigation.

Event Description

As reported: tip of turnpike spiral broke off during rca intervention.They were unable to snare the tip as it was very distal.They entombed / jailed it in a stent.There was a perforation, but the patient was hemodynamically stable.Multiple attempts were made to obtain additional information.

Manufacturer Narrative

Device has not returned for evaluation.If the device is returned, a device investigation will be conducted and a follow-up report will be submitted.

Event Description

Additonal information (medwatch) received 30apr2020 from risk manager at site and medwatch5094178 from fda.The patient underwent successful orbital atherectomy and percutaneous coronary intervetnion of the rca (right coronary artery), extending from ostial rca to the mid pda (posterior descending artery)with overlapping xience des.The procedure was complicated by fracture of a turnpike spiral microcatheter nose cone into the heavily calcified mid pda lesion.This was successfully treated by exclusion of the retained foreign body from the lumen of the vessel using antegrade dissection and re-entry technique.The fractured portion of the microcatheter was not removed because of concern that snaring and pulling at the device would lead to avulsion of the vessel with the potential of death.The procedure was also complicated by wire perforation at the mid pda site.This was successfully treated with prolonged balloon tamponade and protamine infusion.The outcome was confirmed in the cath lab with definity contrast assisted tte demonstrating no extravasation of contrast into pericardium.

Manufacturer Narrative

Investigation details: a manufacturing record review was completed and there were no nonconformances related to this lot therefore supporting the device met material, assembly and performance specifications prior to shipment.One unit of turnpike spiral was returned to vsi/teleflex for investigation.Minor blood particulates were found on the hub of the catheter.The catheter was decontaminated using a germicide and further inspected.About 0.6cm of the turnpike spiral was sheared off from the distal end of the catheter.No other damage was found along the length of the catheter.The following specifications were measured using a ruler and snap gauge: o.D.At the spiral tip, o.D.At the distal tip, o.D.At the proximal section.Catheter and o.D met specifications.No other damage was found on the catheter.The damage to the tip could have most likely occurred due to misuse of the catheter.As per ifu, two warnings are stated: never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury.Do not rotate the catheter more than two (2) consecutive 360° rotations in either direction if the distal tip becomes lodged and is not also rotating, as it may result in separation of the catheter, damage to the catheter, or vessel injury.If using the turnpike spiral or turnpike gold, rotate the catheter in the counterclockwise direction with backward tension in order to dislodge the tip.The account was inquired on questions related to over torqueing of the catheter, any resistance experienced, and concomitant devices used by the physician.No response was received.Based on the information and returned product evaluation, the most likely root cause of the issue is operational context and/or unintended use error.Based on the information and returned product evaluation, the most likely root cause of the issue was operational context and/or unintended use error.

• Brand Name: TURNPIKE SPIRAL
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 9984130
• MDR Text Key: 188826706
• Report Number: 2134812-2020-00033
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K191560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2021
• Device Model Number: 5640
• Device Lot Number: 648706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 75