MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC MICRO INTRODUCER KIT; CATHETER

Model Number	7268
Medical Device Problem Code	Device Or Device Fragments Location Unknown (2590)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	06/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was reported as discarded.The event description states that the hub on the sheath separated from the shaft upon removing from the patient's body.A manufacturing record review was completed and zero nonconformances were found that were related to this failure.There was no returned product to complete an evaluation.Therefore, the root cause for this failure is undeterminable.
Event or Problem Description
Four (4) french sheath and dilator were advanced over the wire.When the dilator and the wire pulled out, the hub of the sheath was pulled out without the body of the shaft of the sheath.This was cut/got separated for an unknown reason.To retrieve the shaft of the sheath, obtained a contralateral access in the left groin.A micropuncture needle was used.We upgraded it for a 6 french sheath.Angiography was obtained with the tip of the catheter in the left external iliac artery.We advanced wire and catheter.Selective abdominal aortogram was performed.We crossed over to the contralateral side using the catheter and this wire.We then advanced the wire down the sfa.After that we exchanged this system out for a 7 french sheath, 45 cm.The tip of the catheter was in the right external iliac artery.Tried to snare it initially, but this did not work.Then tried to advance wire into the sheath that cut to externalize it but this did not work either.Tried using a different wire but this did not work either.Obtained a surgical consult.After that, obtained a right common femoral arterial access using the micropuncture needle, advanced a 6 french sheath.Then was able to snare the 4 french sheath which was in the right external iliac artery using a 6 french snare.The whole length of the shaft was intact.

• Brand Name: MICRO INTRODUCER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6728278
• Report Number: 2134812-2017-00060
• Device Sequence Number: 670413
• Product Code: DYB
• UDI-Device Identifier: M2069217V1
• UDI-Public: M2069217V1
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K101604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2017

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: No Information
• Device Expiration Date: 08/18/2019
• Device Model Number: 7268
• Device Lot Number: 597685
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 84