MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE; NONE

Model Number VPR-GW-FT14

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/03/2017

Event Type  Injury  

Event Description

This is an (b)(6) y/o woman who had progressive worsening changes the left third toe with dry gangrene, underwent a vascular eval with balloon angioplasty.Noted postop the pt a wire tip sheared off into the peritoneal artery with instability to stand, subsequent placement of a stent preventing thrombosis placement occurring in the peroneal artery.Using a long 6-french sheath, we got a wire across the occlusion, we tried to exchange for a viper wire but the tip of the viper sheared off when it crossed the stenosis.The wire tip sheared off into the peroneal artery.We attempted to snare out, but these were too large to fit into the artery.We tried to get balloon and pushed back indoor catheter, but it did not work.We therefore elected to leave the wire in place.We covered it with a stent to prevent any thrombosis occurring and the peroneal artery, so that wire was now basically excluded from the circulation by that stent.This is a defect in the mfr's wire which is now being reviewed by the mfr and the hospital.The tp trunk had a stenosis as well, which we removed with a 3.5 x 4 angioscore balloon.Completion angiogram showed a great result was better filling of the foot, but evidence again of severe microvascular disease the long 6-french sheath was exchanged for a short 6 and we used a mynx closure device.

• Brand Name: VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE
• Type of Device: NONE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. ; st. paul MN 55112
• MDR Report Key: 6689792
• MDR Text Key: 79247506
• Report Number: 6689792
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 181424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2017
• Distributor Facility Aware Date: 05/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 71