MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 38270

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/16/2020

Event Type  Injury  

Event Description

It was reported that tip detachment occurred.An imager ii catheter was selected for use in a renal embolization procedure.The imager ii was placed into the body over a.035 non-bsc guidewire.While screening the catheter through the heart it was noted that the distal part of the catheter became detached.This ended up floating off the wire and was initially lodged in the aorta.A snare was then used in an attempt to retrieve the catheter tip, but on two occasions the snare sliced through the catheter and therefore there were then three pieces of catheter tip floating through the arteries.The snare was used to successfully retrieve one of these pieces and was removed from the right circumflex femoral artery.A long different snare was then used to attempt to snare the remaining pieces which had now travelled more distal, but without success.The main body of the catheter tip has become lodged within the right posterior tibial artery and a smaller piece has also become lodged in the right dorsalis pedis artery.The right foot was viable.After approximately three hours of attempting to remove the fragments, it was decided to leave the fragments within the patient rather than operate since the patient also has metastatic cancer.The renal embolisation was completed as was the original desired procedure for the patient using a different device.Post operatively both pt and dp pulses where and remain present and the patients foot continued to be warm to touch.No adverse effects were noted by the clinical staff within two days of the event.The patient was in stable condition.

Event Description

It was reported that tip detachment occurred.An imager ii catheter was selected for use in a renal embolization procedure.The imager ii was placed into the body over a.035 non-bsc guidewire.While screening the catheter through the heart it was noted that the distal part of the catheter became detached.This ended up floating off the wire and was initially lodged in the aorta.A snare was then used in an attempt to retrieve the catheter tip, but on two occasions the snare sliced through the catheter and therefore there were then three pieces of catheter tip floating through the arteries.The snare was used to successfully retrieve one of these pieces and was removed from the right circumflex femoral artery.A long different snare was then used to attempt to snare the remaining pieces which had now travelled more distal, but without success.The main body of the catheter tip has become lodged within the right posterior tibial artery and a smaller piece has also become lodged in the right dorsalis pedis artery.The right foot was viable.After approximately three hours of attempting to remove the fragments, it was decided to leave the fragments within the patient rather than operate since the patient also has metastatic cancer.The renal embolisation was completed as was the original desired procedure for the patient using a different device.Post operatively both pt and dp pulses where and remain present and the patients foot continued to be warm to touch.No adverse effects were noted by the clinical staff within two days of the event.The patient was in stable condition.

Manufacturer Narrative

Device evaluated by mfr: device analysis was performed on the returned device.It was noticed that the device showed a separation of the tip located 2 cm from the tip edge.63 cm of the device was returned, and as the device is manufactured at 6 cm long, 2 cm was not returned.Materials analysis testing of the tip was performed and revealed that the area was brittle.A kink located 23 cm from the strain relief was noticed.During analysis and due to the extremely fragility of the device, the device cracked approximately 61 cm from the strain relief.No other damage was noticed on the devices shaft.Inspection of the remainder of the device, apart from the observed damage on the box, revealed no other damage or irregularities.

• Brand Name: IMAGER II ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10191775
• MDR Text Key: 196325681
• Report Number: 2134265-2020-08495
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729355656
• UDI-Public: 08714729355656
• Combination Product (y/n): N
• PMA/PMN Number: K121694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2020
• Device Model Number: 38270
• Device Catalogue Number: 38270
• Device Lot Number: 0000133414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 92484513-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR