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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: requested, not provided.Date of birth: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.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.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that the doctor was treating a peripheral arterial disease (pad) in the left leg, he accessed the right femoral artery via ultrasound and a 5fr cook micro-puncture kit, then exchanged it for a 5fr 11 cm cordis sheath.No resistance was met.With a 260 cm stiff zip wire and a 65 cm omni catheter, he navigated his wire over the iliac bifurcation to the left common iliac and down the left superficial femoral artery (sfa).The doctor then removed his catheter and the 5fr cordis sheath to exchange for a 6fr sheath straight to a pinnacle destination sheath.As he tried to advance the sheath over the wire into the access site, resistance was met and stopped.It was noted that the tip of the destination sheath seemed to be damaged.A new destination sheath was opened and inserted into the access site with no issues.The case was completed, and successful hemostasis was achieved using an abbott perclose device.The patient was in stable condition.The outcome of the procedure was successful.The blood loss was less than 250cc's.Additional information was received on 16november2020: the type of damage that was noticed on the device was a fish mouth at the tip of sheath.The dilator was normal and not damaged.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9 and to update section h3.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to update section h3, and to provide the completed investigation results.One 5fr 45 cm destination sheath was received for product evaluation.The sheath was mated with dilator when received.The sheath was subjected to visual analysis and damage was observed on the tip of the sheath.Microscopy confirmed that the sheath tip was damaged in a fashion where there was a bulge and a fold on the tip of the sheath.The outer diameter of the sheath was measured to be 0.098 inches which is within specification.The dilator od measured 0.072 inches which is within specifications.The complaint can be confirmed for sheath tip mechanical damage.Based on the damage observed, it is likely that the damage on the sheath tip can be attributed to difficulties at the point of insertion, possible due to scar tissue or calcification.The sheath tip is designed to be soft and atraumatic to minimize rollback of the sheath when entering the body.Inadvertent exposure of the tip of hard surfaces before use can lead to deformation.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 failure mode and effects analysis (fmea).

• Brand Name: DESTINATION PERIPHERAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 10994868
• Report Number: 1118880-2020-00318
• Device Sequence Number: 16341533
• Product Code: DYB
• UDI-Device Identifier: 00389701008912
• UDI-Public: 00389701008912
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 54-54501
• Device Lot Number: YG17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 12/14/2020; 01/14/2021
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 01/07/2021; 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 260 CM STIFF ZIP WIRE
• Patient Age: 56 YR
• Patient Weight: 107