MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83779
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Separation Failure (2547); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was broken.A 2mm x 4cm interlock was selected for use in a renal embolization to treat a pseudoaneurysm.During the procedure, it was noted that the device was broken.The procedure was completed with a non boston scientific device.No patient complications were reported.
Additional Manufacturer Narrative
Weight: 73.5 kg.
Event or Problem Description
It was reported that the device was broken.A 2mm x 4cm interlock was selected for use in a renal embolization to treat a pseudoaneurysm.During the procedure, it was noted that the device was broken.The procedure was completed with a non boston scientific device.No patient complications were reported.The patient was originally hospitalized on (b)(6) 2022 with chief complaint of generalized malaise, fatigue and concern of anemia.He was received last (b)(6) 2022 post inguinal orchiectomy secondary to necrotic testicle, with spontaneous right sub capsular renal and retroperitoneal hematoma.It was further reported via medwatch# mw5110234 that the vascular access was obtained via femoral artery.During the procedure, the coil was attempted to be deployed but it would not detach.Upon checking, it was noted that the coil was broken off into two separate pieces and was not in the catheter where it should have been.It was assumed that the break occurred prior to opening the device, possibly during packaging or during transport.The device was completely removed by carefully pulling negative suction on the catheter, while simultaneously pulling the catheter out of the patient, and was verified with fluoroscopy over the patient.No further patient complications reported.
Additional Manufacturer Narrative
A4 - weight: 73.5 kg.Device evaluated by mfr: the device was returned for evaluation.Only the main coil was returned.It was inspected, and no damages were found.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14806350
• Report Number: 2134265-2022-06853
• Device Sequence Number: 4677418
• Product Code: KRD
• UDI-Device Identifier: 08714729845263
• UDI-Public: 08714729845263
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: 09/06/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0028164346
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER- TERUMO- PROGREAT 2.4
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male