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

Model Number	N/A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(6).The actual device has been returned to the manufacturing facility 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 while inserting the r2psheath over the wire in the radial artery there was a lot of resistance from spasm.The doctor proceeded to push the sheath in, the coils began to get closer together and absorb the force.The blood loss was reported to be less than 250cc's.The patient condition was reported to be stable.The procedure outcome was to abandoned radial access and go with femoral access to complete the procedure.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide an update and to provide the completed investigation results.One 6fr 149 cms r2p sheath was received with a mated dilator for evaluation.No other components were returned.Visual inspection revealed no kinks or folds in the sheath.In two areas a zigzag 'accordion' deformation was noted on the outer surface.In the distal part, some roughness was felt which was examined under a microscope and it was noted that in these spaces the sheath had folded over itself on the surface throughout the circumference.The sheath was soaked in water and was checked digitally for breaks in coating.No anomalies were found and a continuous slippy surface was noted.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the crimped pattern on the outer surface was caused due to longitudinal and transverse insertion and withdrawal forces which would be experienced in the reported event.However, the exact cause of the reported event cannot be definitively determined.

• Brand Name: R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 7938110
• Report Number: 1118880-2018-00149
• Device Sequence Number: 2254895
• Product Code: DYB
• UDI-Device Identifier: 00389701011561
• UDI-Public: 00389701011561
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171491
• 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): 10/05/2018

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C15W
• Device Lot Number: WD28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/31/2018
• 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: R2P BABY J
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 71