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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in moderately tortuous and non-calcified left forearm vein.A 7.0mmx40mmx80cm (4f) sterling balloon catheter was advanced and dilated the central side without problem.The same device was used to expand the lesion on the peripheral side.The balloon was inflated twice.However, during the second inflation at 6 atmospheres, the lesion could not be dilated and the elution of the contrast medium from the balloon was recognized as a ruptured.It was noted that there was no appearance of a rupture when the central side expands.The device was removed without any problem.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient condition was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The balloon folds were loosely folded and there is contrast present inside the device.Functional testing was performed by inflating the device to rated burst pressure and it was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in moderately tortuous and non-calcified left forearm vein.A 7.0mmx40mmx80cm (4f) sterling balloon catheter was advanced and dilated the central side without problem.The same device was used to expand the lesion on the peripheral side.The balloon was inflated twice.However, during the second inflation at 6 atmospheres, the lesion could not be dilated and the elution of the contrast medium from the balloon was recognized as a ruptured.It was noted that there was no appearance of a rupture when the central side expands.The device was removed without any problem.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient condition was good.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15115347
• Report Number: 2124215-2022-27306
• Device Sequence Number: 14841306
• Product Code: DQY
• UDI-Device Identifier: 08714729124108
• UDI-Public: 08714729124108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: 02/28/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0028961170
• 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: 07/21/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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: GUIDEWIRE USED: GLITTER 160; GUIDEWIRE USED: GLITTER 160; INTRODUCER SHEATH USED: MEDIKIT 4FR; INTRODUCER SHEATH USED: MEDIKIT 4FR
• Patient Sex: Male