MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER AMPLATZ TYPE RENAL SHEATH; DILATOR, URETHRAL

Model Number	M0069001230
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report pertains to one of two complaint devices used in the same procedure.Manufacturer report 3005099803-2017-01812 addresses the nephromax dilatation balloon, while manufacturer report # 3005099803-2017-01814 addresses the amplatz renal sheath.It was reported to boston scientific corporation that a nephromax dilatation balloon was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, when they used a 20 cm amplatz renal sheath, it would not slide over the nephromax dilatation balloon.As they pushed to slide the sheath over the balloon, the balloon advanced and perforated the renal pelvis.It is unknown if there was additional intervention performed for the punctured renal pelvis.The procedure was not completed due to this event.Post procedure, there were no complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
A visual examination and product analysis of the returned renal sheath of this device found a slight bent at the proximal section.This failure is likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.However, the event, tissue perforation, is identified as anticipated in nature and severity.Therefore, the most probable root cause is anticipated procedural complication, as a device related root cause does not apply in this event and the complaint is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.A review of the device history record (dhr) was performed and confirmed that this device was manufactured in accordance with the device master record.A search of the complaint database revealed that no other complaints exist for the specified lot.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
Event or Problem Description
Note: this report pertains to one of two complaint devices used in the same procedure.Manufacturer report 3005099803-2017-01812 addresses the nephromax dilatation balloon, while addresses the amplatz renal sheath.It was reported to boston scientific corporation that a nephromax dilatation balloon was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, when they used a 20 cm amplatz renal sheath, it would not slide over the nephromax dilatation balloon.As they pushed to slide the sheath over the balloon, the balloon advanced and perforated the renal pelvis.It is unknown if there was additional intervention performed for the punctured renal pelvis.The procedure was not completed due to this event.Post procedure, there were no complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• Brand Name: AMPLATZ TYPE RENAL SHEATH
• Common Device Name: DILATOR, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6646212
• Report Number: 3005099803-2017-01814
• Device Sequence Number: 757076
• Product Code: KOE
• UDI-Device Identifier: 08714729431671
• UDI-Public: (01)08714729431671(17)20190831(10)18256090
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K870695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2017

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: 08/31/2019
• Device Model Number: M0069001230
• Device Catalogue Number: 900-123
• Device Lot Number: 18256090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 08/29/2017
• 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: Other
• Patient Age: 60 YR