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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Embolus (1830)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.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 tip of the sheath broke during a chronic limb ischemia case.The doctor removed the sheath and noticed the broken tip.There was difficulty removing the broken tip.Emboli was caused that was suctioned out.The case was completed using a shorter sheath.The patient was stable and the procedure was completed.Additional information was received 14january2019: the vessels were heavily calcified.The tip of the sheath stayed attached.The clot was suctioned, not the sheath tip.The patient did not suffer any damage due to the tip embolizing.The brand of the shorter sheath used to replace the broken destination sheath was a pinnacle sheath.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction, to provide additional information to the b5 and c11 section, to update the h3 section and to provide the completed investigation results.In the initial report it was reported in the b5 section that the additional information date was (b)(6)2029.However, the date should have been (b)(6)2020.One 6 fr 90 cm destination sheath was received for product evaluation.Visual inspection revealed that damage was seen at the tip of the sheath.The soft tip was observed under microscope and was found to be nearly separated from the sheath shaft.Upon examination, it was observed that there was discontinuity in the melt bond of soft tip material to the sheath.Based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.However, the exact cause of the reported event cannot be determined based on the available information.Terumo has determined the reported event to be manufacturing related and is being further investigated.
Event or Problem Description
Additional information was received on (b)(6)2020 : normal force was applied to guide the destination sheath though the calcified vessels.The left mid superficial femoral artery (sfa) was being treated.Heparin was used and the act (activated clotting time) goal was above 250.The tip of the sheath was noticed to be broken after removal for sheath exchange.The broken tip was still partially attached to the sheath.Prior to the removal of the sheath, no balloons were cut and no dcb's (drug-coated balloon) were used to treat the cli (chronic critical limb ischemia).The severity of the calcification was mild.Blood flow was brisk.There was no scar tissue.Distal embolus was aspirated with the aspiration catheter.Sheath was exchanged for a shorter sheath, 6fr x 45 cm sheath.

• Brand Name: DESTINATION CAROTID GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 9676351
• Report Number: 1118880-2020-00027
• Device Sequence Number: 19499204
• Product Code: DYB
• UDI-Device Identifier: 00389701007847
• UDI-Public: 00389701007847
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: RSC05
• Device Lot Number: XA23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 02/22/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/17/2020
• 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: HEPARIN; PINNACLE SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 90