MAUDE Adverse Event Report: CORDIS CORPORATION RAIN SHEATH TRANSRADIAL; INTRODUCER, CATHETER

Catalog Number	506610S
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date is unknown.As the sterile lot number was not available, device history record review could not be performed.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 6f 10cm sw rain sheath trans-radial sheath introducer accordioned and got stuck in the patient's arm.There were no reports of patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 6f 10cm sw rain sheath trans-radial sheath introducer accordioned and got stuck in the patient's arm.There were no reports of patient injury.A product history record (phr) review could not be performed because the lot number for this product is unknown.Without the return of the device or images for analysis, the reported customer event ¿catheter sheath introducer (csi)-accordioned¿ and ¿csi- withdrawal difficulty¿ could not be confirmed.Procedural factors such as continuing to insert the device against resistance may have ultimately led to the subsequent withdrawal difficulty.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿if resistance is felt upon insertion or withdrawal, investigate the cause before continuing.¿ an investigation to address events of csi-accordioned has already been initiated.No further action will be taken at this time.
Event or Problem Description
As reported, a 6f 10cm sw rain sheath trans-radial sheath introducer accordioned and got stuck in the patient's arm.There were no reports of patient injury.The device was not returned for evaluation.

• Brand Name: RAIN SHEATH TRANSRADIAL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16784913
• Report Number: 9616099-2023-06470
• Device Sequence Number: 5522399
• Product Code: DYB
• UDI-Device Identifier: 10705032078948
• UDI-Public: 10705032078948
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 506610S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown