MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P DESTINATION SLENDER GUIDING SHEATH; INTRODUCER, CATHETER

Model Number N/A

Device Problem Break (1069)

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

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).Implanted date: device was not implanted.Explanted date: device was not explanted.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.For this reason, investigation conclusions code 11 has been referenced in section h6.A review of the device history record of the product code/lot# combination was conducted with no findings.

Event Description

The user facility reported that the 6fr destination r2p glidesheath slender 119cm separated at the hub of the sheath when removing from the body.There was no harm to the patient and the patient was in stable condition.The procedure outcome was successful.The procedure was a peripheral r2p intervention via left radial approach.There was little to no calcium and no tortuosity.Additional information was received on 04dec2020.The doctor stated that there was some "accordion" when inserting and removing product from the hub.They were able to remove the device from the patient without any medical intervention.

Event Description

Additional information was received on 01feb2021.The user facility noted that the vessel was small and that there was some twisting/torqueing of the device while it was being used.The insertion of the device went well with no issues or complications.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in section b5, update section h3, and to provide the completed investigation results.One 119 cm 6fr r2p destination sheath and dilator were returned for product evaluation.Visual inspection of the sheath revealed that the tip of the sheath was broken off 0.59in from the sheath hub at the distal end of the strain relief.There were kinks noted along the sheath shaft at 3.14in, 6.5in, 18.9in, 21.4in, 24.5in, and 37.4in from the hub.No other anomalies were noted.Dimensional testing was performed.The sheath outer diameter (od) measured to be 0.0996in which was within the manufacturer's specifications.The sheath inner diameter (id) measured to be 0.086in which was within the manufacturer's specifications.The dilator was subjected to visual inspection and no anomalies were noted.The complaint can be confirmed for sheath mechanical separation.It is likely that pulling forces during withdrawal of the sheath in the presence of resistance likely caused the breakage.Per the product ifu: "while inserting or withdrawing, if resistance is met, do not advance or withdraw the sheath until the cause of resistance has been determined." the device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: R2P DESTINATION SLENDER GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11074443
• MDR Text Key: 230324397
• Report Number: 1118880-2020-00336
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: 00389701011547
• Combination Product (y/n): N
• PMA/PMN Number: K193125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: XG05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MISAGO STENT; R2P BALLOON; SUPPORT CATHETERS; WIRES
• Patient Age: 62 YR
• Patient Weight: 57