MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION URETERAL CATHETER; CATHETER, URETHRAL

Model Number	M0064002011
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
Note: this report pertains to one of two flexima ureteral catheter balloon used during the same procedure.It was reported to boston scientific corporation that two flexima ureteral catheter balloons were unpacked for a procedure on (b)(6) 2019.According to the complainant, there are two open end ureteral catheters devices in which the seal on the packaging were open.Reportedly, the devices were bad and unable to be used since they were unsterile.The procedure was completed with another flexima ureteral catheter balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
Note: this report pertains to one of two flexima ureteral catheter balloon used during the same procedure.It was reported to boston scientific corporation that two flexima ureteral catheter balloons were unpacked for a procedure on (b)(6) 2019.According to the complainant, there are two open end ureteral catheters devices in which the seal on the packaging were open.Reportedly, the devices were bad and unable to be used since they were unsterile.The procedure was completed with another flexima ureteral catheter balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
(b)(4).Block h10: a visual examination of the returned complaint device confirmed that the pouch of the device was opened from the chevron side, compromising the seal.There was evidence of the heat seal ran through out the entire length of the pouch without any break.It is most likely that the failures found are related to the inappropriate transport or storage of the device; therefore the most probable root cause is cause traced to transport/storage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: URETERAL CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8441626
• Report Number: 3005099803-2019-01402
• Device Sequence Number: 11028559
• Product Code: GBM
• UDI-Device Identifier: 08714729342083
• UDI-Public: 08714729342083
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K870694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

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: 01/10/2022
• Device Model Number: M0064002011
• Device Catalogue Number: 400-201
• Device Lot Number: 0023172806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1