MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET AVX; CATHETER, EMBOLECTOMY

Model Number	45026
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was stuck on the wire.An angiojet avx catheter and a 180amplatz guidewire were selected for an av graft declot procedure.During the procedure, the catheter would not pull back over the wire.One ring got caught on the wire and would not let the physician retract the wire.The tubing to the console was cut in order to remove the wire and catheter together.There were no patient complications reported.The procedure was completed with another catheter.
Event or Problem Description
It was reported that the catheter was stuck on the wire.An angiojet avx catheter and a 180amplatz guidewire were selected for an av graft declot procedure.During the procedure, the catheter would not pull back over the wire.One ring got caught on the wire and would not let the physician retract the wire.The tubing to the console was cut in order to remove the wire and catheter together.There were no patient complications reported.The procedure was completed with another catheter.Returned product consisted of portion of the avx thrombectomy system with approximately 12cm of the.035" guidewire for the related complaint.Majority of the effluent line and supply line were cut-off and not returned for analysis.The pump and pump assembly were also not returned for analysis.The effluent/supply line and shaft were visually inspected.Blood was present outside and inside the device when received.Visual inspection of the device revealed that the effluent and supply lines were cut-off 7cm distal of the barb luer and the shaft was kinked 22cm and 25cm distal of the strain relief.The distal portion of the shaft was detached and stretched at the proximal markerband and proximal window.The markerband was moved distally on the outer shaft.The hypotube was also detached 1cm distal of the proximal window.The rest of the distal shaft, including the tip, and the hypotube were not returned for analysis.The distal saddle and jet body were detached and received on the returned guidewire.The saddle was damaged and portion of the jet body was detached from the hypotube and still connected to the distal saddle.The saddle/jet body was able to be removed from the guidewire with some resistance, as the guidewire was damaged with coating peeling off.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: ANGIOJET AVX
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8085342
• Report Number: 2134265-2018-62959
• Device Sequence Number: 11178719
• Product Code: DXE
• UDI-Device Identifier: 08714729889045
• UDI-Public: 08714729889045
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2020
• Device Model Number: 45026
• Device Catalogue Number: 45026
• Device Lot Number: 0022627677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/10/2018
• Patient Sequence Number: 1
• Patient Age: 55 YR