MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

A1: patient identifier: not available due to hospital policy.A2: age & date of birth: not available due to hospital policy.A3: patient sex: not available due to hospital policy.A4: weight: not available due to hospital policy.A5: ethnicity: not available due to hospital policy.A6: race: not available due to hospital policy.D4: lot number: requested, unknown.D4: expiration date: unknown due to unknown lot number.D4: udi: unknown due to unknown lot number.D6b: explanted date: device was not explanted.E3: occupation: lead cath lab tech.H4: device manufacture date: unknown due to unknown lot number.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.

Event Description

The user facility reported that they attempted to use the angio-seal device to close a 6f access site.The device malfunctioned; however, they were able to complete the closure successfully.After using the arteriotomy locator, they pulled out the dilator and inserted the closure device through the sheath successfully, clicked in place successfully, and pulled the device with normal pressure according to instructions for use (ifu).While pulling, the physician felt a snap in the suture.He then cut off the top portion of the closure device so he could continue pulling with pressure and tamp down on the tamper tube.The device seemed to be placed successfully, despite the suture breaking.There was no patient injury or blood loss.Additional information was received on 21aug2023: the patient was stable and was discharged the same day.There were no issues with initial sheath access or guidewire and catheter exchanges.There were no issues with initial insertion of the angio-seal device.A pre-deployment angiogram was performed.

Manufacturer Narrative

This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.One 6fr angio-seal vip was returned for product evaluation.The returned sample included the hemostasis sheath and carrier tube assembly.The returned sample was subjected to visual analysis.The returned device was covered in blood-like substances.The hemostasis sheath was not mated to the carrier tube assembly.The locking mechanism on the carrier tube assembly was set to rear lock position.There was a kink on the carrier tube assembly.The suture was fully released from the carrier tube assembly with the black compaction marker and clear stop released from the carrier tube assembly.There were no cuts on the carrier tube assembly or hemostasis sheath.From the state of the returned device, the complaint cannot be confirmed for suture detachment since the suture was still in the carrier tube assembly.The suture showed signs of being cut by a sharp object like a scalpel or blade.The overall state of the returned device was consistent with full deployment and no visual anomalies were found.As a results, the condition in which the device was returned contradicts the reported allegation.The cause of the suture detachment could not be determined from the returned device.The device history record (dhr) could not be reviewed since the lot number was not provided.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).

• Brand Name: 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset NJ 00873
• Manufacturer (Section G): TERUMO PUERTO RICO LLC; innovacion street lot 21; caguas west industrial park; caguas, 00725
• Manufacturer Contact: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 17675035
• MDR Text Key: 322844018
• Report Number: 3013394970-2023-00422
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 610130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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