MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION UNKNOWN 9F PINNACLE SHEATH; INTRODUCER, CATHETER

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

Expiration date - unknown due to the lot number being unknown.Udi - unknown due to the lot number being unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Manufacture date - unknown due to the lot number being unknown.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

Event Description

The user facility reported that they had a problem with a 9f pinnacle sheath.When they removed the introducer from the sheath the backstop had been pushed through and a stream of blood came out.The introducer was placed back in the sheath and the sheath was exchanged for another.

Manufacturer Narrative

This report is being submitted as follow up no.2 to the update to the device evaluated by mfr and to provide the completed investigation results.One 9fr introducer sheath and the dilator were received for product evaluation.Visual inspection revealed that the valve was nested in the sheath hub where the top and bottom of the valve are oriented parallel to the sheath hub.Reviewed introducer kit ifu and per the product ifu: "insert the dilator into the valve center of the sheath.Forced insertion of the dilator which misses the center of the sheath valve may cause damage, and result in blood leakage." based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the dilator was inserted off-center into the valve, dislodging the valve from its intended orientation.However, the exact cause of the reported event cannot be definitely determined based on the available information.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in the d10 section and to update the h 3 section.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

• Brand Name: UNKNOWN 9F PINNACLE SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8743618
• MDR Text Key: 149516845
• Report Number: 1118880-2019-00161
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K954234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1