MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH IMAGER II UROLOGY TORQUEABLE CATHETER; CATHETER, UROLOGICAL

Model Number	M0064005031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 an imager renal dilator was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2018.According to the complainant, once the device was inserted, the catheter peeled off.The procedure was completed with another imager renal dilator device.The patient's condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation that an imager renal dilator was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2018.According to the complainant, once the device was inserted, the catheter peeled off.The procedure was completed with another imager renal dilator device.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Investigation results: visual examination of the returned complaint device noted that the shaft was damaged horizontally.The damage was noted at 10.5cm from the tip and traveled proximally to 14cm from the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Based on the evaluation of the returned device, it has been identified that the damage was consistent with a procedural interaction with another medical device.Therefore, the most probable root cause is caused by other device.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: IMAGER II UROLOGY TORQUEABLE CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7457522
• Report Number: 3005099803-2018-01216
• Device Sequence Number: 1006671
• Product Code: KOD
• UDI-Device Identifier: 08714729430346
• UDI-Public: 08714729430346
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K011965
• 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): 04/04/2018

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: 11/30/2019
• Device Model Number: M0064005031
• Device Catalogue Number: 400-503
• Device Lot Number: 0000127833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1