MAUDE Adverse Event Report: COOK INCORPORATED PERFORMER; INTRODUCER, CATHETER

Model Number	G27022
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	01/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
While performing a right popliteal and tibial artery angioplasty, the cook 4fr sheath came apart at the hub in the pt's artery.Multiple attempts to retrieve the sheath were made while staying endovascular.Surgeons needed to cut down on pt's leg to open artery and retrieve the sheath.Pt had to be converted from monitored anesthesia care (mac) to general anesthesia.
Event or Problem Description
While performing a right popliteal and tibial artery angioplasty, the cook 4fr sheath came apart at the hub in the pt's artery.Multiple attempts to retrieve the sheath were made while staying endovascular.Surgeons needed to cut down on pt's leg to open artery and retrieve the sheath.Pt had to be converted from monitored anesthesia care (mac) to general anesthesia.Please describe the other products and equipment used during the procedure (endoscope type and model, introducer, wire guide, etc.): cath.Pd, viatrac 4mm x 30mm x 135cm.Catheter balloon 4 x 80 x 150 armada 18.Catheter balloon 2 x 200 x 150 armada 19.Catheter balloon 6 x 20 x 150 armada 18.Catheter balloon 6 x 80 x 150 armada 18.Catheter balloon armada 14 2.0mm/200mm on 150cm.Catheter balloon armada 14 2.5mm/120mm on 150cm.Catheter balloon armada 14 2.5mm/200mm on 150cm.Catheter balloon armada 14 2.5mm/40mm on 150cm.Catheter balloon armada 14 2.5mm/80mm on 150cm.Catheter balloon armada 14 3.0mm/200mm on 150cm.Catheter peripheral dilatation viatrac 14 plus 4 mm x 20 mm / 135 cm.Catheter peripheral dilatation viatrac 14 plus 4 mm x 40 mm / 135 cm.Catheter support navicross 4fr 135cm straight.Catheter support navicross 4fr 90cm angled.Catheter support navicross 4fr 90cm straight.Catheter.Support quick cross.035 x 150 cm.Suture medicated closure system.Graft 6mm x 10cm 120cm viabahn.Did the patient have a pre-existing condition and/or pre-diagnosis relevant to this event? critical limb ischemia with foot ulcer.Diabetes mellitus foot.Did the event result in a death? no.Were there any adverse effects on the patient due to this occurrence? patient developed large ulcer in the posterior calf to the heel due to worsening ischemia and the occlusion of posterior tibial artery where the catheter retained.Please specify adverse effect(s) and provide details: we used this sheath to access the posterior tibial artery.The catheter part of the sheath was detached and inserted into the posterior tibial artery.To retrieve this catheter, we moved this up to the popliteal artery.We then converted the procedure to open procedure to remove.Postoperatively, patient showed occluded posterior tibial artery that was patent prior to the procedure.The patient developed large posterior calf to heel ulcer and currently receives continuous wound care.Possibly he needs below the knee amputation if this wound is not getting better.He also received additional angioplasty to improve his cli, and wound debridement, nursing home admission etc.What was patient outcome post-retrieval? as described above.Is the device available for return and will tracking by provided? we plan to retain the device at this time.

• Brand Name: PERFORMER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7302263
• Report Number: 7302263
• Device Sequence Number: 19408375
• Product Code: DYB
• UDI-Device Identifier: 00827002270220
• UDI-Public: (01)00827002270220
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018
• Report Date (Section F): 02/09/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 11/01/2018
• Device Model Number: G27022
• Device Catalogue Number: RCFN-4.0-18-5.5-RA1.5
• Device Lot Number: 6336690
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 82
• Date Report Sent to FDA: 02/09/2018