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

Model Number N/A

Device Problems Material Separation (1562); Unraveled Material (1664); Difficult to Advance (2920)

Patient Problems Bradycardia (1751); Calcium Deposits/Calcification (1758); Stroke/CVA (1770); Pain (1994); Paralysis (1997); Obstruction/Occlusion (2422); Embolism/Embolus (4438); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 06/27/2022

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: cath lab director.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 number combination was conducted with no findings.

Event Description

The user facility reported that the involved r2p guiding sheath device was used to access the ulnar artery and upon withdrawal the sheath broke and unwound.The physician was not able to advance the sheath past the brachial artery.The physician was able to remove the partial sheath.It was unknown if the dilator was used when they tried to remove the sheath.There was no patient injury, and no medical or surgical intervention was required.Additional information was received on (b)(6) 2022: terumo medical received a user facility medwatch report number (b)(4): other information about the patient that may have influenced the outcome of the event: per vascular surgeon's notes: the patient was a 73-year-old female apparently collapsed at home after an episode of chest pain and was resuscitated for approximately 10 minutes with cardiopulmonary resuscitation (cpr) by standby individual.She was taken to another facility initially, was incoherent and had a combative history.She required intubation and was noted to have st-elevation myocardial infraction (stemi) on electrocardiogram (ekg).She developed bradycardia requiring transcutaneous pacing.She was then taken to the cardiac catheterization laboratory (ccl) by a interventional cardiologist and was noted to have a complete occlusion of the right coronary artery.She underwent a percutaneous coronary intervention (ptca) and stent placement.She also had subsequent intervention to the left anterior descending artery (lad) as well.The patient tolerated the procedure and was brought back to the intensive care unit (icu).Two days after the procedure, the vascular surgeon was consulted on ischemic left lower leg.The md's notes stated that she was unresponsive, on a ventilator, had a left hemiparesis consistent with an acute cerebrovascular accident (cva).She has continued to deteriorate requiring massive doses of three pressors, remained unresponsive and as such with the acute myocardial infraction (mi) with cardiogenic shock, troponins were at the level of 46,000 and acute cva.She was not a candidate for any peripheral vascular surgical intervention.Patient presented with acute limb ischemia of the left lower extremity and the patient was discussed with vascular surgeon and the plan was to bring the patient to cardiac catheterization laboratory (ccl) and do an angiogram and try to re-vascularize the left leg.Patient was deemed a poor surgical candidate.Adequate images of the left femoral artery and serial images of the left lower extremity were obtained.Obviously, the patient had difficult access and the plan was to go and do it from the right groin.However, the right groin showed a total occlusion of the femoral artery and the common iliac artery.The plan was to go the right radial approach.Radial artery pulse was very weak, so they went through the right ulnar artery.It was successfully cannulated with ultrasound guidance.A 6fr sheath was then inserted.The short sheath was upgraded to a long terumo sheath to re-vascularize the left superficial femoral artery (sfa).There was some difficulty advancing the sheath due to calcification and spasm in the right ulnar artery.The sheath was slid down to about the mid abdominal level and would not go any further.The plan was to pull it out since it would not reach the left sfa.While pulling the catheter, at least moderate difficulty and a piece of the guide catheter was left in place and it was embedded in the right ulnar artery.The piece was about 5-6 centimeters long.Multiple attempts were made to retrieve the piece.Finally, a cutting balloon (3.5 x 15) was advanced into the catheter (into the broken catheter); it was pulled out along with the sheath in the right ulnar artery.Hemostasis was achieved with a blood pressure cuff.The right ulnar artery started bleeding and a tr band was applied successfully.Patient tolerated the procedure well without any further complications.The patient was transferred to icu in stable condition.The original intended procedure was an anterior inter-body infusion (aif) of the left lower extremity right radial cannulation to revascularize the left sfa.Medical conditions that may have contributed to the event was severe calcification of right ulnar/severe spasm.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The sample was not available for evaluation.The complaint cannot be confirmed since the sample was not available for evaluation.The exact root cause cannot be determined.The likely root cause is the continued withdrawal of the sheath in the face of resistance from calcification and spasms.The device history record (dhr) review determined that 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).

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the attached maude report.Terumo tmc performed a maude search on 30 aug 2022.Report number (b)(4) was found and was confirmed to be of the same reported event, and therefore the maude report has been provided.

• Brand Name: R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 15111820
• MDR Text Key: 296666009
• Report Number: 1118880-2022-00059
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: 00389701011547
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: 0000147188
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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
• Treatment: COOK SUPPORT CATHETER; CUTTING BALLOON (3.5 X 15); TR BAND
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Hispanic
• Patient Race: White