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

Model Number G17558

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2019

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

It was reported that during an irrigation and angiography on one side of the fallopian, a modified novy cornual cannulation set was used.After the distal tip of the introducing catheter was inserted into the patient it partially detached.The operator immediately removed the catheter from the patient, the partially detached tip was also removed.The procedure was then completed with another modified novy cornual cannulation set.No adverse effects to the patient were reported due to this occurrence and no portion of the device remained inside the patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Ec method code desc - 5: communication/interviews (4111).Investigation - evaluation: reviews of complaint history, device history record, manufacturing instructions, quality control data, and trend analysis were 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.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.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 related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The complainant did not return the complaint device to cook for investigation.A definitive cause of the reported event could not be determined.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.

Event Description

No additional patient or event information has been received since the last report was submitted on 17oct2019.

• Brand Name: MODIFIED NOVY CORNUAL CANNULATION SET
• Type of Device: MOV CATHETER, SALPINGOGRAPHY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9204253
• MDR Text Key: 175751948
• Report Number: 1820334-2019-02639
• Device Sequence Number: 1
• Product Code: MOV
• UDI-Device Identifier: 00827002175587
• UDI-Public: (01)00827002175587(17)210312(10)8659230
• Combination Product (y/n): N
• PMA/PMN Number: K931476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

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: 03/12/2021
• Device Model Number: G17558
• Device Catalogue Number: J-NCS-504070
• Device Lot Number: 8659230
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 58