MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿; CATHETER, PERCUTANEOUS

Model Number	H74939032804080
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified basilic vein.A 8.0mmx40mmx80cm (4f) sterling¿ balloon catheter was advanced for dilation.However, during initial inflation at 14 atmospheres for 30 seconds, the balloon ruptured.No segment of the balloon was detached inside the patient after it ruptured.The procedure was completed with a different size sterling balloon catheter.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The balloon was loosely folded.There was contrast and blood in between balloon folds.The balloon, markerbands, proximal bond and tip were microscopically examined.Functional testing using an inflation device was used to inflate the balloon to the rated burst pressure and revealed a pinhole in the balloon material.Microscopic examination of the balloon presented no irregularities in the balloon material, markerband and proximal bond that could have contributed to the damage.Inspection of the remainder of the device revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as it was reported that the complaint device was inflated at 14 atmospheres which is above its rated burst pressure.The sterling dfu states; "maintain negative pressure on the balloon between inflations.Do not exceed the rated balloon burst pressure." (b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified basilic vein.A 8.0mmx40mmx80cm (4f) sterling¿ balloon catheter was advanced for dilation.However, during initial inflation at 14 atmospheres for 30 seconds, the balloon ruptured.No segment of the balloon was detached inside the patient after it ruptured.The procedure was completed with a different size sterling balloon catheter.There were no patient complications reported.

• Brand Name: STERLING¿
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6394100
• Report Number: 2134265-2017-01877
• Device Sequence Number: 30547
• Product Code: DQY
• UDI-Device Identifier: 08714729720690
• UDI-Public: (01)08714729720690(17)20190430(10)0019173833
• Combination Product (Y/N): N
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2017

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: 04/30/2019
• Device Model Number: H74939032804080
• Device Catalogue Number: 39032-80408
• Device Lot Number: 0019173833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: KYUOSHA; INFLATION DEVICE: BOSTON; INTRODUCER SHEATH: MEDIKIT