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

Model Number	24694
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Codes	Hematoma (1884); Vomiting (2144)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device entrapment and removal difficulties were encountered.The patient also experienced vomiting and a hematoma.The 80-95% stenosed, 300mm, complex multilevel heavily calcified target lesion was located in the moderately tortuous femoral popliteal artery.A 6f non-boston scientific sheath and a 300cm, 8cm v-18 control wire were placed.A 4.0 mm x 220 mm x 150 cm sterling balloon catheter was advanced for dilatation.The balloon was inflated thrice at 14 atmospheres for 2 minutes.The device was then fully deflated.The device was attempted to be removed off the wire.Removal difficulties were encountered.The hypotube of the sterling balloon catheter prolapsed and the hypotube kinked distally as a result from the removal difficulties.The physician removed the entire system intact along with the 6f sheath.It was also reported that the patient experienced a hematoma and vomiting.The physician performed a superficial femoral artery (sfa) recanalization and a computerized tomography scan (ct scan) was performed to rule out retroperitoneal hematoma (rph).The procedure was completed.The patient fully recovered.
Event or Problem Description
It was reported that froze on wire occurred; and the patient experienced vomiting and hematoma.The 80-95% stenosed, 300mm, complex multilevel heavy calcium target lesion was located in the moderately tortuous and calcified femoral popliteal artery.A 6f non-boston scientific sheath and a 300cm, 8cm v-18 control wire were placed.A 4.0 mm x 220 mm x 150 cm sterling balloon catheter was advanced for dilatation.The balloon was inflated thrice at 14 atmospheres for 2 minutes.The device was then fully deflated and the device was attempted to be removed off the wire.The physician pin pulled the device or attempted to be pin pulled off wire and it was noticed that the balloon prolapsed and the hypotube was bent.The physician removed the entire system including the sheath.The patient had hematoma and vomiting.The physician performed a supercial femoral aftery (sfa) recanulization and a computerized tomography scan (ct scan) was performed to rule out retroperitoneal bleed or hematoma (rph).The procedure was completed.The patient fully recovered.It was further reported that the hematoma was located in the groin.The retroperitoneal bleed was ruled out.The caused of patient's vomiting was reversal of protamine as per medical opinion.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11507773
• Report Number: 2134265-2021-02874
• Device Sequence Number: 2777075
• Product Code: LIT
• UDI-Device Identifier: 08714729859291
• UDI-Public: 08714729859291
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 02/27/2022
• Device Model Number: 24694
• Device Catalogue Number: 24694
• Device Lot Number: 0025944860
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/03/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/21/2021
• 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: 65 YR