MAUDE Adverse Event Report: TELEFLEX MEDICAL CLIP-UNKNOWN; Clip, implantable

Catalog Number SURGICAL UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 06/13/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).No sample available for investigation.

Event Description

A 63-year-old man had undergone a laparoscopic right hemicolectomy for appendix cancer and a cholecystectomy for adenomyomatosis of the gallbladder.The pathological diagnosis was gallbladder cancer, and he was referred to our hospital for a liver resection.He underwent laparoscopic liver s4b and s5 resections and lymph node dissections.Ml napcs were placed at the cut surface of the liver, the cystic artery, the cystic duct, and the right gastric artery (fig.5a).In addition, l napcs were placed at the glissonean pedicle of segment 5.Three months after the operation , a follow-up mrcp suggested that bile duct stenosis had formed, and another ercp was performed (fig.5b).A napc was found when the endoscopic biliary drainage tube was removed (fig.5c).Based on the endoscopic images, the migrated napc was about 1 cm in size; thus, we presumed it was an ml napc.We concluded that the napcs used to clip the cystic duct had migrated into the common bile duct.After the napc was removed, balloon dilatations were performed twice, and the stenosis disappeared.Currently, the patient is under observation without stenting.Catalog #: unknown lot #: unknown.Complaint was published in the article attached herewith by the mds of the customer.

Event Description

A 63-year-old man had undergone a laparoscopic right hemicolectomy for appendix cancer and a cholecystectomy for adenomyomatosis of the gallbladder.The pathological diagnosis was gallbladder cancer, and he was referred to our hospital for a liver resection.He underwent laparoscopic liver s4b and s5 resections and lymph node dissections.Ml napcs were placed at the cut surface of the liver, the cystic artery, the cystic duct, and the right gastric artery (fig.5a).In addition, l napcs were placed at the glissonean pedicle of segment 5.Three months after the operation , a follow-up mrcp suggested that bile duct stenosis had formed, and another ercp was performed (fig.5b).A napc was found when the endoscopic biliary drainage tube was removed (fig.5c).Based on the endoscopic images, the migrated napc was about 1 cm in size; thus, we presumed it was an ml napc.We concluded that the napcs used to clip the cystic duct had migrated into the common bile duct.After the napc was removed, balloon dilatations were performed twice, and the stenosis disappeared.Currently, the patient is under observation without stenting.Catalog #: unknown lot #: unknown.Complaint was published in the article herewith by the mds of the customer.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review could not be conducted since the lot number of the device was not provided.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: CLIP-UNKNOWN
• Type of Device: Clip, implantable
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15099540
• MDR Text Key: 304508290
• Report Number: 3003898360-2022-00368
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SURGICAL UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1