MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UROMAX ULTRA; DILATOR, CATHETER, URETERAL

Model Number	M0062251270
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and 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 uromax ultra dilatation balloon catheter was used in the urinary duct during a transurethral dilatation procedure performed on an unknown date.According to the complainant, while unpacking, a hair was found in the device.The procedure was completed with another uromax ultra dilatation balloon catheter.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilatation balloon catheter was used in the urinary duct during a transurethral dilatation procedure performed on an unknown date.According to the complainant, while unpacking, a hair was found in the device.The procedure was completed with another uromax ultra dilatation balloon catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Correction: block d4: lot number block e1: initial reporter phone block h4: device manufacture date block g1: manufacture site address block b3: date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: problem code 2944 captures the reportable issue of foreign matter.Block h10: investigation results visual examination of the returned complaint device found that the device was coiled within its tray inside an open inner pouch.It was noted that a hair was inside the opened pouch.Based on the available information, no evidence of a manufacturing issue, design or user issue which could have caused the complaint.However, since no specific failure was reported, the more probable cause could not be established due to lack of information.Therefore, the most probable root cause is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

• Brand Name: UROMAX ULTRA
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10161961
• Report Number: 3005099803-2020-02341
• Device Sequence Number: 17037204
• Product Code: KOE
• UDI-Device Identifier: 08714729341345
• UDI-Public: 08714729341345
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 02/17/2022
• Device Model Number: M0062251270
• Device Catalogue Number: 225-107
• Device Lot Number: 0023361646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1