MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number UNK-P-JAGWIRE

Device Problems Break (1069); Entrapment of Device (1212); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(b)(4).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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a jagwire guidewire was used in the common bile duct during an ercp (endoscopic retrograde cholangio-pancreatography) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the jagwire guidewire got stuck after the stent was released.The metal corewire was broken into two pieces after the physician pulled it out.The procedure was completed with this device.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a jagwire guidewire was used in the common bile duct during an ercp (endoscopic retrograde cholangio-pancreatography) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the jagwire guidewire got stuck after the stent was released.The metal corewire was broken into two pieces after the physician pulled it out.The procedure was completed with this device.There were no patient complications reported as a result of this event.Additional information received on (b)(6) 2020: reportedly, the coating was peeled and corewire was not broken/fractured.

Manufacturer Narrative

Additional information: b5, h6 (device codes) block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.Block h6 (device codes): problem code 1069 captures the reportable event of corewire break.Block h6 (evaluation conclusion codes): 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 mdr will be filed.

• Brand Name: JAGWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9746034
• MDR Text Key: 190381746
• Report Number: 3005099803-2020-00590
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-P-JAGWIRE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1