MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066401041
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ethnicity: white.Date of event was approximated to (b)(6) 2019 as the event occured in (b)(6) 2019.This event was reported to the fda via a voluntary medwatch report.The user facility reference number is (b)(4).(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 amplatz super stiff guidewire was used during a placement of ureteral stent via guidewire and open laparotomy procedure performed in (b)(6) 2019.According to the complainant, during procedure, the physician was placing a ureteral stent, he made a high urethrotomy incision to pass a 5-french angle-tipped ureteral catheter down the ureter into the bladder.Via cystoscopy, he passed an amplatz guidewire up to the ureter.The guidewire was backloaded in the cystoscope and over the wire, stent was placed.The stent was difficult to advance and felt that the guidewire was bent.When the guidewire was removed, it broke and unraveled.Upon inspection of the wire by the surgeon, he felt it he had all the pieces.X-ray showed no foreign body in the area except the intended ureteral stent.However, post evaluation by the urologist identified the proximal end of the stent is bent over on itself and will need to be removed at a later date with possible replacement needed in 6-12 weeks.Reportedly, the initial surgery for pelvic mass removal was a laparoscopic approach.However, upon entering the abdominal cavity, the size of the mass could not be removed via laparoscope.The procedure was converted to an open laparoscopy.Prior to the procedure, the primary surgeon has placed a 24 cm uretral stent in the left ureter.The lower end of this stent migrated to the distal end of the ureter and consulted urology to assist with repositioning/removal.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9535520
• Report Number: 3005099803-2019-06363
• Device Sequence Number: 14050288
• Product Code: EZB
• UDI-Device Identifier: 08714729191148
• UDI-Public: 08714729191148
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/31/2019

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: 05/21/2022
• Device Model Number: M0066401041
• Device Catalogue Number: 640-104
• Device Lot Number: 0023836344
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 71