MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) JAGWIRE¿; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number M00556581

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over 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.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to one of the two devices used during the same procedure.Refer to manufacturer report # 3005099803-2016-03445 for the wallflex enteral colonic stent and 3005099803-2016-03431 for the jagwire.It was reported to boston scientific corporation on (b)(6) 2016 that a wallflex enteral colonic stent and a jagwire guidewire were used in the sigmoid colon during a stent placement procedure performed on (b)(6) 2016.The indication for stent placement was as palliative care to treat a malignant stricture due to large intestine cancer.Reportedly, the patients anatomy was tortuous and the patient had no previous chemotherapy or radiation therapy.According to the complainant, during the procedure, the physician inserted the wallflex enteral colonic stent (the subject to mfr report # 3005099803-2016-03445) over the jagwire guidewire (the subject mfr report # 3005099803-2016-03431).The physician experienced difficulty crossing the wallflex and jagwire through the tortuous anatomy and it was noted that the patient started experiencing pain.Contrast imaging was done before deploying the stent and it was noted that the contrast agent was found leaking out of the intestinal tract and a perforation was confirmed.The stent and the guidewire were removed.The patient underwent a surgery where the tumor and the perforation were resected.According to the complainant, in the physicians assessment, the delivery system of the stent and the guidwire contributed to the perforation.The patient condition at the conclusion of the surgery was reported to be stable and there were no other patient complications reported.

• Brand Name: JAGWIRE¿
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6106947
• MDR Text Key: 60041277
• Report Number: 3005099803-2016-03431
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K141820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00556581
• Device Catalogue Number: 5658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention