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

Model Number G17558

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported while preparing for a tubal intubation procedure using a modified novy cornual cannulation set, when assembling the spring coil, the coil got stuck in 3fr catheter.The procedure was completed with a new device.There were no adverse effects to the patient as a result of this occurrence.Physical evaluation of the returned complaint device revealed that a 2 cm long fragment of the wire guide had separated and was lodged inside the catheter.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Event description: it was reported on (b)(6) 2020 that while using a modified novy cornual cannulation set , reportedly ¿when assembling the spring coil, the coil got stuck in 3fr catheter.The procedure was completed by using another new device.No adverse effect reported." investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, and quality control data.One modified novy cornual cannulation set.Was returned for investigation.Visual examination noted the returned catheter measured 55cm, and there was a metal coil inside the catheter 0.3cm from the hub.The coil measured 1.7cm and appeared to be a fragment of a wire guide.The catheter felt like it has been pulled and stretched starting from 4cm from the distal tip.An attempt to push wire guide from the catheter was unsuccessful.The investigator cut a portion of the catheter and was able to push the metal coil fragment.The fragment of the wire guide was 2cm in length, and the outside diameter was 0.018cm.The wire guide fragment had off set coils.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 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.A review of complaint history records shows no other complaints associated with the complaint device lot.It was determined that these current controls are sufficient manufacturing and inspection steps to identify this failure.Most probable cause cannot 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.

• 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: 10164032
• MDR Text Key: 196425027
• Report Number: 1820334-2020-01142
• Device Sequence Number: 1
• Product Code: MOV
• UDI-Device Identifier: 00827002175587
• UDI-Public: (01)00827002175587(17)220124(10)9471648
• 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: 07/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2022
• Device Model Number: G17558
• Device Catalogue Number: J-NCS-504070
• Device Lot Number: 9471648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 06/23/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 54