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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation-nurse manager.(b)(4).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.(b)(4).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 destination catheter broke and unraveled in the patient's vessel.The destination was used in the groin for femoral access, standard angiogram; up and over.Shots were taken in the superficial femoral artery (sfa) and as they moved catheter back to take image of iliac, the catheter became stuck.They pulled and the tip came apart stretching the wire braiding out.This seemed to shear off the tip of the amplatz guidewire.They managed to get all parts out by cutting down at groin.Additional information was received on 16feb2021.The patient condition was very poorly; he was similar to a man of 80 years old and they were reluctant to anesthetize him.There was blood loss, as they had to cut into groin to get device out.Additional information was received on 23feb2021.The statement: shots were taken in the superficial femoral artery (sfa) means angiogram images were taken.
Additional Manufacturer Narrative
One used 6 fr 45 cm destination sheath was received for product evaluation.The dilator was partially mated to the sheath when received.No other accessory components were returned.Visual inspection revealed that the shaft of the sheath had broken into four pieces.In addition to this, the sheath was stretched severely throughout in a fashion that the sheath broke with the stainless-steel coil within the sheath exposed.Ifu states: "advance or withdraw the sheath slowly.If resistance is met, do not advance or withdraw the sheath until the cause of the resistance has been determined." the sheath can be confirmed for sheath catheter mechanical breakage.The ifu cautions stating "advance or withdraw the sheath slowly.If resistance is met, do not advance or withdraw the sheath until the cause of the resistance has been determined.It is likely that the manipulation of the sheath in presence of resistance could have potentially led to the stretching and breakage of the sheath since the damage was observed at the end of the procedure.This implies that the sheath was able to advance and intervene without any issues.The sources that contributed to the breakage of the sheath cannot be 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.
Event or Problem Description
Additional information was received on 31mar2021.The condition of the vasculature of the patient was lt critical lib ischemia with iliac and sfa disease.There was calcified arteries and scarred groin.Before the wire braiding came out, there was some resistance was they tried to pull the sheath back, the source of resistance was not identified.The sheath was put first on the dilator then dilator was removed to take angio and do the angioplasty.There was not a catheter within the sheath.There was no catheter, there was wire only.The body of the sheath shortly after tip was broken through plastic cover but the supporting wire kept it attached.The sheath got caught in the lt eia.It is believed that the support wire of the sheath sheared off of the tip of the amplatz guidewire.

• Brand Name: DESTINATION RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11410592
• Report Number: 1118880-2021-00032
• Device Sequence Number: 3381806
• Product Code: DYB
• UDI-Device Identifier: 00389701006185
• UDI-Public: 00389701006185
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: RSR03
• Device Lot Number: YE01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/16/2021
• 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: AMPLATZ GUIDE WIRE; AMPLATZ GUIDE WIRE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR