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

Model Number	G32224
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k) number: pre-amendment.Investigation evaluation.Reviews of the dimensional verification, complaint history, device history record, instructions for use (ifu), manufacturer¿s instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one separated kcfw-6.0-38-40-rb-blkn-hc was returned for investigation.The sheath tubing was fully separated to the distal hub, and the dilator was not returned.There was biomatter throughout the device.The proximal flare was caught securely in the hub.There was 5mm of sheath tubing extending out of the connector cap.The separated tubing section contained 2.2cm of coil on the proximal end.The total length of tubing was 41.5cm.There was an elongated section which measured 9.3cm, starting 1.3cm from the distal tip.The distal tip was intact, and the marker band was still present.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, specifications, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which warns to reinsert the dilator prior to removal.Based on the information provided and the examination of the returned product, investigation has concluded that this event can be traced to the user and unintended use error.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported, during a left lower limb thrombectomy and angioplasty procedure involving an (b)(6) year old female patient, the shaft of the flexor balkin guiding sheath separated from the hub.Access was gained via the right groin for a crossover angioplasty.It is unknown if the patient's anatomy was scarred, calcified, or tortuous.The procedure lasted three hours; however, the placement of the device "maybe lesser than that duration".Reportedly, no resistance was noted during insertion or removal of the device.The dilator was not reinserted prior to the removal attempt, but the wire guide was.Both the hub and shaft of the sheath were removed at the conclusion of the procedure.A section of the device did not remain inside the patient¿s body.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.
Additional Manufacturer Narrative
This mdr is being submitted as having information not previously reported.Additional complaint investigation and record remediation was not performed.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.
Event or Problem Description
No new patient or event information since the last report was submitted.

• Brand Name: FLEXOR BALKIN GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8755044
• Report Number: 1820334-2019-01597
• Device Sequence Number: 1926155
• Product Code: DYB
• UDI-Device Identifier: 00827002322240
• UDI-Public: (01)00827002322240(17)211214(10)9382864
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: G32224
• Device Catalogue Number: KCFW-6.0-38-40-RB-BLKN-HC
• Device Lot Number: 9382864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 03/19/2020
• Patient Sequence Number: 1
• Patient Age: 89 YR