MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number 8900

Device Problems Material Deformation (2976); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

The shaft showed 1 kink located at the ocb handle.The tip showed stretched coils.There was some coating peeled from the wire at the 93cm kinked area.There was indication of body fluids in the sensor housing.The comet wire was not connected to the ocb when returned.The wire was connected to the handle to check signal strength.The signal was not present as designed.The wire was removed from the ocb handle with a restriction.It did take a fair amount of tensile pull to remove it.The inside of the cap was inspected and found that there was damage.The collet was jammed in and stuck in the cap which caused the collet not to let go of the wire.It is possible during the assembly process of the ocb handle the wire was inserted into the collet and as the cap was tightened the collet became skewed and jammed in the cap.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint was confirmed for unlocking issues.

Event Description

It was reported that difficulty disconnecting a pressure guidewire occurred.During the disconnection of a comet from the wire connector, the wire couldn't be pulled out.After the procedure, the wire was completely disconnected from the connector and it was noticed that two v shaped bends were present on the hidden proximal part of the wire.Ffr was not performed with this wire.No patient complications were reported in relation to this event.However, returned device analysis revealed peeled/sheared coating.

Event Description

It was reported that difficulty disconnecting a pressure guidewire occurred.During the disconnection of a comet from the wire connector, the wire couldn't be pulled out.After the procedure, the wire was completely disconnected from the connector and it was noticed that two v shaped bends were present on the hidden proximal part of the wire.Ffr was not performed with this wire.No patient complications were reported in relation to this event.However, returned device analysis revealed peeled/sheared coating.

Manufacturer Narrative

Correction to (evaluation conclusion code): changed from design inadequate for purpose to unintended use error caused or contributed to event.Correction to (device evaluation): changed from: device evaluated by mfr: the shaft showed 1 kink located at the ocb handle.The tip showed stretched coils.There was some coating peeled from the wire at the 93cm kinked area.There was indication of body fluids in the sensor housing.The comet wire was not connected to the ocb when returned.The wire was connected to the handle to check signal strength.The signal was not present as designed.The wire was removed from the ocb handle with a restriction.It did take a fair amount of tensile pull to remove it.The inside of the cap was inspected and found that there was damage.The collet was jammed in and stuck in the cap which caused the collet not to let go of the wire.It is possible during the assembly process of the ocb handle the wire was inserted into the collet and as the cap was tightened the collet became skewed and jammed in the cap.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint was confirmed for unlocking issues.Changed to: device evaluated by mfr: the shaft showed 4 kinks.The kinks were located at the ocb handle, 93cm from the tip.The device showed 2 kinks inside of the ocb handle at the collet area.The tip showed a kink/bends and stretched coils.There was some coating peeled from the wire at the 93cm kinked area.No body fluids in the sensor housing.The comet wire was connected to the ffr link for signal verification.The signal was not present as designed.The wire was being removed from the ocb handle.The ocb connector cable was loosened 1 turn to remove the wire from the handle.The wire would not exit the collet or handle.The turn knob was loosened and taken off the ocb handle.The collet was gently moved back and forth until the collect came loose from the cap.The inside of the cap was inspected and found that there was damage.The collet was jammed in and stuck in the cap which caused the collet not to let go of the wire.It is possible during the assembly process of the ocb handle the wire was inserted into the collet and as the cap was tightened the collet became skewed and jammed in the cap.If the wire entered the slots of the collet and the cap was tightened the internal kinks on the wire inside of the ocb handle may have occurred.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8455300
• MDR Text Key: 139970989
• Report Number: 2134265-2019-02953
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (y/n): N
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

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: 10/02/2020
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0022738882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1