MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY PRO; CATHETER, PERCUTANEOUS

Model Number	8103
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an upgrade procedure from a dual-chamber pacemaker to a cardiac resynchronization therapy pacemaker (crt-p), a hook catheter and a 130-degree internal catheter were used.After slitting both the catheters, the spiral s catheter was dislocated.An iron man wire was advanced through the lead and the lead was retracted.A new hook catheter was advanced over the wire and a piece of the previous internal catheter was found in the carotid sinus, the piece could not be salvage with a snare catheter.The piece of internal catheter detached and dislocated into a hepatic vein.An attempt to salvage the catheter via the femoral groin was also not possible.The physician then decided to leave the piece in the vein.No additional adverse patient effects were reported.The remaining part of the internal catheter will return for analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the catheter was performed.The catheter returned with the tip portion missing.A visual inspection revealed the catheter with the cut-down/slit was not straight, the separated ends were jagged with braiding exposed, multiple bent/kinked and the tip portion was missing.The findings suggest that there was trouble with cutting the device by the physician during the procedure.
Event or Problem Description
It was reported that during an upgrade procedure from a dual-chamber pacemaker to a cardiac resynchronization therapy pacemaker (crt-p), a hook catheter and a 130-degree internal catheter were used.After slitting both the catheters, the spiral s catheter was dislocated.An iron man wire was advanced through the lead and the lead was retracted.A new hook catheter was advanced over the wire and a piece of the previous internal catheter was found in the carotid sinus, the piece could not be salvage with a snare catheter.The piece of internal catheter detached and dislocated into a hepatic vein.An attempt to salvage the catheter via the femoral groin was also not possible.The physician then decided to leave the piece in the vein.No additional adverse patient effects were reported.The remaining part of the internal catheter was returned for analysis.

• Brand Name: ACUITY PRO
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC MAPLE GROVE; 2 scimed place; maple grove MN 55311
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15612910
• Report Number: 2124215-2022-41625
• Device Sequence Number: 20625330
• Product Code: DQY
• UDI-Device Identifier: 08714729932543
• UDI-Public: 08714729932543
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: Health Professional
• Device Expiration Date: 12/23/2023
• Device Model Number: 8103
• Device Catalogue Number: 8103
• Device Lot Number: 28604969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 10/16/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown