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

(b)(4).There is no available information regarding the device.

Event Description

An 81-year-old woman had previously undergone a laparoscopic right hemi-hepatectomy for intrahepatic bile duct cyst adenocarcinoma at the age of 79 years.Napcs were used in the operation.She was followed up in the post-operative outpatient clinic.Two years after the operation, she underwent an upper gastrointestinal (gi) endoscopy to investigate a complaint of epigastric pain.The results showed one medium-large (ml, 1.0 cm) napc at the anterior side of the duodenal bulb (fig.1a).The patient was given a proton pump inhibitor, which relieved the epigastric pain.Follow-up gi tests were performed 2 months after the first upper gi endoscopy.These tests revealed two ml napcs at the duodenal bulb (fig.1b).In the previous operation, ml napcs had been placed at the cystic duct, the right hepatic artery, and the posterior branch of the portal vein.In addition, large (l, 1.3 cm) napcs were placed at the right hepatic duct and the anterior and posterior branches of the portal vein.A metal clip was placed at the cystic artery (fig.2a).When the migrated napc was found in the duodenal bulb, a computed tomography (ct) scan was performed.Reconstruction ct imaging showed two ml napcs at the duodenal bulb and one metallic clip nearby (fig.2b).Considering the distance that the metal clip migrated from its placement on the gallbladder artery, we concluded that the ml napcs used to clip the cystic duct must have migrated to the duodenal wall.The patient characteristics and results are summarized in table 1.Catalog #: unknown and lot #: unknown.Complaint was published in the article attached herewith by the mds of the customer.No sample available for investigation.

Event Description

An 81-year-old woman had previously undergone a laparoscopic right hemi-hepatectomy for intrahepatic bile duct cyst adenocarcinoma at the age of 79 years.Napcs were used in the operation.She was followed up in the post-operative outpatient clinic.Two years after the operation, she underwent an upper gastrointestinal (gi) endoscopy to investigate a complaint of epigastric pain.The results showed one medium-large (ml, 1.0 cm) napc at the anterior side of the duodenal bulb (fig.1a).The patient was given a proton pump inhibitor, which relieved the epigastric pain.Follow-up gi tests were performed 2 months after the first upper gi endoscopy.These tests revealed two ml napcs at the duodenal bulb (fig.1b).In the previous operation, ml napcs had been placed at the cystic duct, the right hepatic artery, and the posterior branch of the portal vein.In addition, large (l, 1.3 cm) napcs were placed at the right hepatic duct and the anterior and posterior branches of the portal vein.A metal clip was placed at the cystic artery (fig.2a).When the migrated napc was found in the duodenal bulb, a computed tomography (ct) scan was performed.Reconstruction ct imaging showed two ml napcs at the duodenal bulb and one metallic clip nearby (fig.2b).Considering the distance that the metal clip migrated from its placement on the gallbladder artery, we concluded that the ml napcs used to clip the cystic duct must have migrated to the duodenal wall.The patient characteristics and results are summarized in table 1.Catalog #: unknown and lot #: unknown.Complaint was published in the article attached herewith by the mds of the customer.No sample available for investigation.

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: 15099477
• MDR Text Key: 304557932
• Report Number: 3003898360-2022-00317
• 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: 11/16/2022
• 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
• Treatment: N/A.