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

Model Number	M00556161
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was under the age of 18.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-06471 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex colonic stent was to be implanted to treat an approximately 6cm malignant colonic obstruction in the sigmoid colon during a colonoscopy with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, post patient sedation, the physician had difficulty passing the delivery system over the guidewire and had difficulty advancing the delivery system towards the anatomy.Reportedly, the dreamwire guidewire (the subject of this report) got kinked.The physician wanted to exchange the guidewire; however, when the physician attempted to remove the stent from the scope, the wallflex colonic stent (the subject of mfr.Report# 3005099803-2020-06471) deployed prematurely inside the scope.The stent was removed and the procedure was not completed as another stent was unavailable.There were no patient complication reported as a result of this event.

• Brand Name: DREAMWIRE
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11100526
• Report Number: 3005099803-2020-06375
• Device Sequence Number: 3786215
• Product Code: EZB
• UDI-Device Identifier: 08714729777861
• UDI-Public: 08714729777861
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/31/2020

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 Model Number: M00556161
• Device Catalogue Number: 5616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1