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

Model Number G48187

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, prior to use during a below-the-knee percutaneous transluminal angioplasty, the hub of a flexor raabe guiding sheath leaked as the device was flushed with saline.The device did not make patient contact.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

No new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, prior to use during a below-the-knee percutaneous transluminal angioplasty, the hub of a flexor raabe guiding sheath leaked as the device was flushed with saline.The device did not make patient contact.Investigation ¿ evaluation: a document based investigation was performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.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 made out of specification.A review of the device history record found one non-conformance potentially related to the reported failure mode; all affected product was scrapped, and there are 100% inspections for this nonconformance.Because there are adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows one other complaint associated with the complaint device lot, reported under manufacturer report # 1820334-2021-00314, from the same facility for the same failure mode.No device was returned for either complaint.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: ¿in order to ensure device compatibility, choose a sheath size large enough to accommodate the maximum outer diameter of any devices that will be placed through the sheath.All interventional or diagnostic instruments used with this product should move freely through the valve and sheath to avoid damage.¿ instructions for use: ¿sheath introduction: ensure that the inner diameter (id) of the sheath is appropriate for the maximum diameter of the instruments to be introduced.Using the side-arm of the valve, flush the sheath by filling the sheath assembly completely with heparinized saline.Flush the dilator with heparinized saline.¿ how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred." a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook could not conclude a cause of failure from the provided information.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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 RAABE GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11259971
• MDR Text Key: 238645417
• Report Number: 1820334-2021-00220
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002481879
• UDI-Public: (01)00827002481879(17)230827(10)13393863
• Combination Product (y/n): N
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2023
• Device Model Number: G48187
• Device Catalogue Number: KCFW-4.0-35-55-RB-RAABE
• Device Lot Number: 13393863
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1