MAUDE Adverse Event Report: MEDIKIT COMPANY LIMITED SUPER SHEATH CBDE; CATHETER, PERITONEAL

Model Number M00542961

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

Patient Problem Perforation (2001)

Event Date 12/03/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a super sheath cbde was used during a laparoscopic cholecystectomy with common bile duct exploration (cbd) procedure performed on (b)(6) 2021.During the procedure, the sheath went over a guidewire into the cbd and created a perforation through the wall of the cbd.The patient then underwent an endoscopic retrograde cholangiopancreatography (ercp) procedure with stent placement.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration, device manufacture dates, and unique identifier (udi) # are unknown.(b)(4).The device has not yet been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration, device manufacture dates, and unique identifier (udi) # are unknown.Block h6: imdrf patient code e2114 captures the reportable event of perforation.Block h6: conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not yet been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Additional information: block d7a updated based on additional information received on february 15, 2022.Correction: block h6, impact code f2301 added to capture placement of stent.

Event Description

It was reported to boston scientific corporation that a super sheath cbde was used during a laparoscopic cholecystectomy with common bile duct exploration (cbd) procedure performed on (b)(6), 2021.During the procedure, the sheath went over a guidewire into the cbd and created a perforation through the wall of the cbd.The patient then underwent an endoscopic retrograde cholangiopancreatography (ercp) procedure with stent placement.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• Brand Name: SUPER SHEATH CBDE
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): MEDIKIT COMPANY LIMITED; 17148-6 aza kamekawa; oaza hichya, hyuga city ; JA
• Manufacturer (Section G): TOGO MEDIKIT CO., LTD.; 17148-6 aza kamekawa; oaza hichya, hyuga city ; JA
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13110313
• MDR Text Key: 282954030
• Report Number: 3005099803-2021-08027
• Device Sequence Number: 1
• Product Code: GBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

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: M00542961
• Device Catalogue Number: 4296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 02/18/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention