MAUDE Adverse Event Report: COOK INC MODIFIED NOVY CORNUAL CANNULATION SET; MOV CATHETER, SALPINGOGRAPHY

Model Number	G17558
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) number = k180552.(b)(4).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 a proximal fallopian tube recanalization, the coating of a modified novy cornual cannulation set detached in the patient's uterine cavity.The physician noted reflective material in the uterine cavity under hysteroscopy-laparoscopy.After further observation, it was confirmed that this material was detached from the blue coating of the device.The physician thus removed the detached material under scope.There has been no report that the patient experienced any adverse effects due to this occurrence.
Event or Problem Description
No new patient or event information since the last report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary: cook was informed of an incident involving a modified novy cornual cannulation set.As reported, during a proximal fallopian tube recanalization procedure, the operator found some reflective material in patient cavity under hysteroscopy-laparoscopy.After further observation, it was confirmed this material was detached from the blue coating of the device.The operator had to remove this debris under scope.No other adverse effects were reported.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, the instructions for use, and quality control data.The complainant returned one modified novy cornual cannulation set.The device was returned with the wire guide inside of the catheter.The coating on the sheath was missing starting at the distal tip and continued 3cm.The catheter was bent 7mm and 5cm from the distal tip.The wire guide was bent 40.2cm from the distal tip.The tip of the stylet was round and smooth.The sheath had a greenish discoloration.The blue coating on the sheath had the appearance of disintegration and a melted appearance where the coating ends inside of the sheath.The sheath was also bent 5mm from the distal tip.A review of the device history record (dhr) 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 device history record 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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A definitive cause of the reported event could not be determined from the available information.The risk analysis for this failure mode was reviewed and additional escalation was not recommend.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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: MODIFIED NOVY CORNUAL CANNULATION SET
• Common Device Name: MOV CATHETER, SALPINGOGRAPHY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10496600
• Report Number: 1820334-2020-01639
• Device Sequence Number: 2889856
• Product Code: MOV
• UDI-Device Identifier: 00827002175587
• UDI-Public: (01)00827002175587(17)220731(10)9918142
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: G17558
• Device Catalogue Number: J-NCS-504070
• Device Lot Number: 9918142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention