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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign body, removal of (2365); No Code Available (3191)

Event Date 07/24/2015

Event Type  Injury  

Event Description

During a fallopian tube recanalization procedure on a (b)(6) female patient with bilateral fallopian tube obstruction, the tip of the catheter broke/separated inside the patient's uterine cavity.The broken tip were removed from the patient by forceps holder.Per information provided to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation.

Manufacturer Narrative

(b)(4).**** event evaluation **** a review of complaint history, device history record, instructions for use (ifu), quality control and a visual examination of the returned product was conducted during the investigation.A visual inspection of the opened and used device noted that the distal tip of that catheter had separated circumferentially ~1 cm from the bond site.The split tips id material appeared brittle and degraded.With exception to the split material, the remaining tip material was pliable.There is no evidence to suggest that the product was not manufactured to specifications.This product is shipped with an ifu which states under storage and handling instructions: "avoid extended exposure to light." / warnings: "due to thin wall construction of this catheter, extreme care must be exercised during manipulation and withdrawal to prevent pulling the catheter apart.Reshaping of the tip is not recommended.Damage can result when exposed to heat." we are unable to determine with certainty why this failure mode occurred.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

During a fallopian tube recanalization procedure on a (b)(6) year old female patient with bilateral fallopian tube obstruction, the tip of the catheter broke/separated inside the patient's uterine cavity.The broken tips were removed from the patient by forceps holder.Per information provided to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: BEACON TIP ANGLED SELECTIVE SALPINGOGRAPHY CATHETER
• Type of Device: MOV CATHETER, SALPINGOGRAPHY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4964015
• MDR Text Key: 6639972
• Report Number: 1820334-2015-00481
• Device Sequence Number: 1
• Product Code: MOV
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K931476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: N/A
• Device Catalogue Number: J-SSG-504000
• Device Lot Number: U2409898
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2015
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 60