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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

During a fallopian tube catheter recanalization procedure on a (b)(6) female patient with fallopian tube occlusion, the beacon-tip separated intrauterine during the sonosalpingography procedure.The doctor removed the catheter and wire guide together by use of a vascular clamp inserted into the intrauterine.A second procedure was performed with a product from another manufacturer.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event evaluation: a functional test along with a review of the complaint history, device history record, instructions for use (ifu), quality control and a visual inspection of the returned products were conducted during the investigation.One open and seven unopened and sealed products from the complaint lot were returned.Visual exam of the used device confirmed the tip had circumferentially split approximately 3mm distal of the bond joint.Functional testing using minimal pressure on one of the seven sealed catheters was able to re-create the damage, in the same location, as the complaint device.But for the split area, the remaining material was pliable.Microscopic examination of the split tips noted the inner diameter material to be brittle and degraded.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 the root cause for this experienced failure mode.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

During a fallopian tube catheter recanalization procedure on a (b)(6) year old female patient with fallopian tube occlusion, the beacon-tip separated intrauterine during the sonosalpingography procedure.The doctor removed the catheter and wire guide together by use of a vascular clamp inserted into the intrauterine.A second procedure was performed with a product from another manufacturer.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any additional procedures nor 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 UROLOGICAL INC; 1100 west morgan st; spencer IN 47460
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5050703
• MDR Text Key: 24876581
• Report Number: 1820334-2015-00552
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SSG-504000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/07/2015
• Device Age: 22 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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 Age: 36 YR
• Patient Weight: 55