MAUDE Adverse Event Report: COOK INC SELECTIVE SALPINGOGRAPHY CATHETER; MOV CATHETER, SALPINGOGRAPHY

Catalog Number J-SSG-554086

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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, during a hydrotubation, the operator inserted the selective salpingography catheter into the 22° hysteroscope by hand.The catheter could not move forward after it was inserted about 2 centimeters (cm).The operator withdrew the catheter and found the end tip of the catheter was broken off.Requests were made for additional information regarding further details of the event, however, the customer has not provided any further information.No adverse events have been reported as a result of the alleged malfunction.

Event Description

Additional information was received 22aug2018: another new device was used to complete the procedure.The patient did not experience any adverse effect(s) due to this issue.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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, the device history record, drawings, manufacturing instructions, quality control data, and specifications.One device was returned for investigation.The length of the catheter is 39.4 cm in length.A visual examination noted the returned catheter displayed a waviness throughout the catheter.The catheter was found to be flattened approximately 1.5 cm from the distal tip.A stock.038¿ wire guide was passed completely through the catheter.The distal tip measured approximately 4 mm and was noted to be damaged.The device history record review showed there were no non-conformances associated with the reported failure.A search of complaint records revealed this is the only complaint for complaint device lot number 8001113.A review of the current versions of manufacturing instructions and quality inspection documents for this device was done.The complaint device was inspected by quality control per current specification.There is no evidence that suggests that this complaint device was manufactured out of specification.Investigators found that the catheter was flattened near the distal tip and the distal tip was noted to be damaged.A wire guide was still able to be passed all the way through the catheter.The cause for this specific failure mode is not able to be established at this time.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and we will continue to monitor 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

There has been no new information received since the last report was submitted.

• Brand Name: SELECTIVE SALPINGOGRAPHY CATHETER
• Type of Device: MOV CATHETER, SALPINGOGRAPHY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7790079
• MDR Text Key: 117462575
• Report Number: 1820334-2018-02442
• Device Sequence Number: 1
• Product Code: MOV
• UDI-Device Identifier: 00827002173590
• UDI-Public: (01)00827002173590(17)200619(10)8001113
• 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,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2020
• Device Catalogue Number: J-SSG-554086
• Device Lot Number: 8001113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASKU
• Patient Age: 37 YR
• Patient Weight: 65