MAUDE Adverse Event Report: COOK INC PEEL-AWAY SHEATH INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Five 10k status: preamendment.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that the peel-away sheath introducer was cracked at the distal end of the device.This defect was discovered prior to use; accordingly, no patient adverse events resulted from the issue, and no contact with any patient was made.A new product was opened and the procedure continued, with no further complications reported.The device has been returned for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Additional information: report source.A review of documentation, drawing, device history record, manufacturing instructions, specification, complaint history, and quality control data was conducted during the investigation.According to the device failure analysis, it is clear the distal tip of the peel away sheath was split.Although there was evidence of bio-matter on the surface of the device, it was reported that the staff noticed this failure prior to patient contact.It is possible that bio-matter got on the device while the staff inspected/handled the device prior to patient contact.Furthermore, the bio-matter on the device is unrelated to the failure.Although the device passed all dimensional tests and the work order indicated no notable non-conformances, because the split was noticed prior to use, it is reasonable to suggest this failure was manufacturing related.It is possible the tip of the peel-away sheath was damaged during the shipping/handling process; however, the severity of the split/fold at the distal tip further suggests the device was shipped with the failure and was manufactured incorrectly.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record for the plvw-22.0-38 peel-away sheath introducer (lot number 8110117) was reviewed, revealing no notable non-conformances related to the failure.Furthermore, a review of our complaint management system indicated this to be the only failure on the specified lot.Based on the provided information, inspection of returned product and the investigation, the root cause is manufacturing related - operator related.To prevent this error from occurring again, production employees in the sheath and dilator qc department completed manufacturing retraining.We will continue to monitor for similar complaints and have notified the proper personnel about this event.Per the quality engineering risk assessment no further action is required.

• Brand Name: PEEL-AWAY SHEATH INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7126864
• Report Number: 1820334-2017-04453
• Device Sequence Number: 19188202
• Product Code: DYB
• UDI-Device Identifier: 00827002040960
• UDI-Public: (01)00827002040960(17)200801(10)8110117
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: N/A
• Device Catalogue Number: PLVW-22.0-38
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1