MAUDE Adverse Event Report: COOK INC THREE-WAY PLASTIC ROTATING ADAPTER STOPCOCK; KGZ ACCESSORIES, CATHETER

Model Number	G01203
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address= phone: (b)(6).Pma/510(k) number = exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an embolization procedure prior to a hepatectomy, two three-way plastic rotating adapter stopcocks leaked.The embolization procedure involved an unknown microcatheter and "histoacrylic och lipiodol".During preparation for the procedure, leakage was discovered as the complaint devices were flushed with glucose.During the same procedure, another three-way plastic rotating adapter stopcock from a different lot also leaked.That event will be reported under patient identifier 318655.Another device of the same type was used to complete 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.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during an embolization procedure prior to a hepatectomy, two three-way plastic rotating adapter stopcocks leaked.The embolization procedure involved an unknown microcatheter and "histoacrylic och lipiodol".During preparation for the procedure, leakage was discovered as the complaint devices were flushed with glucose.During the same procedure, another three-way plastic rotating adapter stopcock from a different lot also leaked.That event will be reported under patient identifier 318655.Another device of the same type was used to complete the procedure.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, manufacturing instructions, and quality control data.Two stopcocks received used along with 13 sealed devices.Inspection found a crack in the stopcocks.The sealed devices were examined for cracks, 5 stopcocks were found to have cracks.No other issues were identified.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, 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 no other complaints associated with the complaint device lot.There is no product labeling to be reviewed for this complaint.No instructions for use are included with the product packaging.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.Of the 13 sealed devices that were returned 5 were found to have cracks.The remaining 8 devices from the lot were undamaged.The review of the device history record showed evidence to support that the lot was manufactured to specification.With all this information in mind, it is most likely that the devices may have been damaged during either shipping or storage.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: THREE-WAY PLASTIC ROTATING ADAPTER STOPCOCK
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11202878
• Report Number: 1820334-2021-00134
• Device Sequence Number: 3780566
• Product Code: KGZ
• UDI-Device Identifier: 00827002012035
• UDI-Public: (01)00827002012035(17)220512(10)NS7908362
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2022
• Device Model Number: G01203
• Device Catalogue Number: 1PTWS-RA-R
• Device Lot Number: NS7908362
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR