MAUDE Adverse Event Report: COOK INC FLEXOR RTPS GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number N/A

Device Problem Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).510k status: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The customer reported that, when the package of the flexor rtps guiding sheath was opened for a transjugular liver biopsy, it was discovered that the dilator that was included with the introducer had an irregular tip; there appeared to be a split in the tip of the device.The operator attempted to introduce it through the skin of the patient, but subsequently ran into unspecified difficulties.The operator replaced the product with a new device, and no further issues were reported.No anatomical abnormalities were noted at the access site.The customer confirmed that no patient adverse events resulted from the product problem, and no additional procedures were necessitated.The complaint device is reportedly unavailable for return and evaluation.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The appropriate manufacturing documents from the device master record (dmr) pertaining to the reported failure mode were reviewed, revealing no notable gaps in the manufacturing process.Documentation indicates to confirm the distal tip of the dilator is rounded, smooth, free of excessive nicks and debris, and to reject the product if any splits are noted.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.There is no evidence confirming this failure was manufacturing related or shipping/handling related.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: b3, d1, d4, g5, h6, h8, h10.G5-pma/510(k) = k142829.Event summary it was reported that, when the package of the flexor rtps guiding sheath was opened for a transjugular liver biopsy, the tip of the dilator was observed split.The user unsuccessfully attempted to introduce the device before subsequently replacing it.No anatomical abnormalities were noted at the access site.The customer confirmed that no patient adverse events resulted from the product problem, and no additional procedures were necessary.Investigation - evaluation a review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.The appropriate manufacturing documents from the device master record (dmr) pertaining to the reported failure mode were reviewed, revealing no notable gaps in the manufacturing process.Documentation indicates to confirm the distal tip of the dilator is rounded, smooth, free of excessive nicks and debris, and to reject the product if any splits are noted.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The complaint device is shipped with instructions for use (ifu), t_intro_rev2, which states, "upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned and the results of our investigation, a definitive root cause for the device failure could not be determined.Possible causes for the device failure include incorrect tipping during manufacturing or damage incurred during shipping and handling.As no gaps in the manufacturing or quality control process were identified, however, there is objective evidence to suggest that the device was manufactured to specifications.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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: FLEXOR RTPS GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7390814
• MDR Text Key: 104411677
• Report Number: 1820334-2018-00858
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002130814
• UDI-Public: (01)00827002130814(17)210126(10)8538789
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KCFW-10.0-35-RB-RTPS-100
• Device Lot Number: 8538789
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1