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

Model Number M00542961

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a super sheath cbde was used during a laparoscopic cholecystectomy procedure performed on (b)(6) 2021.During the procedure, the sheath kinked and broke about halfway of the total length.The proximal end of the sheath attached to the hub was immediately removed and the other piece was removed using a laparoscopic grasper through one of the ports used during the laparoscopic cholecystectomy.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.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 h6 impact codes: code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the device has been received for analysis; however, the analysis has not yet been completed.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.Block h10: the returned spy super sheath cbde was analyzed, and a visual evaluation noted that only the sheath was returned as the actual product.The broken tip was enclosed.The returned product was investigated and it was confirmed that the sheath tube was torn off at the 95 mm point from the tip of the sheath.Magnifying observation was conducted on the torn-off portion.It was observed that there was a broken section on the sheath tube that might had been made by a sharp instrument.It also looked like the rest of the broken part was detached/torn-off when the sheath was pulled out during the procedure.No other issues with the device were noted.The reported event was confirmed.Per the external manufacturer's analysis report, it is likely that the sheath was damaged by a sharp instrument resulting in the reported event of sheath bend and subsequent break.Therefore, based on that information, the conclusion code selected for this investigation is unintended use error caused or contributed to event, which indicates that the interaction between the user and device, or sample, caused or contributed to the error.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Correction: block g4 updated to exempt.

Event Description

It was reported to boston scientific corporation that a super sheath cbde was used during a laparoscopic cholecystectomy procedure performed on (b)(6) 2021.During the procedure, the sheath kinked and broke about halfway of the total length.The proximal end of the sheath attached to the hub was immediately removed and the other piece was removed using a laparoscopic grasper through one of the ports used during the laparoscopic cholecystectomy.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

• 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): MEDIKIT COMPANY LIMITED; 13-2 yushima 1-chome; bunkyo-ku tokyo 113 ; JA 113
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13118378
• MDR Text Key: 285621415
• Report Number: 3005099803-2021-08062
• Device Sequence Number: 1
• Product Code: GBW
• UDI-Device Identifier: 14543527251959
• UDI-Public: 14543527251959
• 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: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: M00542961
• Device Catalogue Number: 4296
• Device Lot Number: 21D21C1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• 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 Sex: Female