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

Model Number	M0064002011
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Captures the reportable event of packaging foreign matter.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
It was reported to boston scientific corporation that a flexima ureteral catheter was unpacked on an unknown date.According to the complainant, during inspection, a red foreign object was noticed.There was no procedure and patient involved.
Event or Problem Description
It was reported to boston scientific corporation that a flexima ureteral catheter was unpacked on an unknown date.According to the complainant, during inspection, a red foreign object was noticed.There was no procedure and patient involved.
Additional Manufacturer Narrative
Investigation result: a visual examination of the complaint device revealed no visible issues.The device looks under good conditions without evidence of damages or anomalies.Based on the information available and the analysis performed, it was concluded that the investigation conclusion code of this event is cause traced to component failure, since expected or random component failure without any design or manufacturing issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a flexima ureteral catheter was unpacked on an unknown date.According to the complainant, during inspection, a red foreign object was noticed.There was no procedure and patient involved.
Additional Manufacturer Narrative
One flexima ureteral catheter was received totally packaged and sealed inside its original pouch.A visual examination of the complaint device revealed no visible issues.The device looks under good conditions without evidence of damages or anomalies.Reportedly, no foreign matter was found.Based on the information available and the analysis performed, it was concluded that the investigation conclusion code of this event is cause traced to component failure, since expected or random component failure without any design or manufacturing issue.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: 7809162
• Report Number: 3005099803-2018-60106
• Device Sequence Number: 19216387
• Product Code: GBM
• UDI-Device Identifier: 08714729342083
• UDI-Public: 08714729342083
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K870694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2018

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: 06/18/2021
• Device Model Number: M0064002011
• Device Catalogue Number: 400-201
• Device Lot Number: 0022273227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/16/2018; 10/22/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1