MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN TRUSEAL ACCESS SYSTEM; CATHETER, PERCUTANEOUS

Model Number M635TU70020

Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problems Perforation (2001); No Code Available (3191)

Event Date 02/27/2020

Event Type  malfunction  

Event Description

Upon third attempt at deploying the watchman (two #24s previously used, third attempt was also a #24), the physician became concerned about pericardial perforation.Per transesophageal echo (tee), myocardial perforation was noted.Laparoscopic atriclip procedure was then performed.Notes from the procedure: "after confirmation of the correct size of the implantable occlusion device, the angled pigtail was withdrawn, and the device was loaded through the delivery catheter.The outer double curve sheath was then withdrawn over the delivery catheter, and the watchman was deployed into the left atrial appendage.The first deployment was limited, as being not distal enough and left too much of a posterior shoulder.The second deployment appeared more favorable, and device release criteria were then assessed.After confirmation of position, the deployment knob was pulled backwards in an attempt to assure firm anchoring of the deployed system.Deployment failed to pass stability testing, the device was easily dislodged.The decision was made to pursue the anterior lobe.The pigtail was re-advanced through the delivery sheath and into the most anterior lobe.After assurance of free aspiration from watchman delivery sheath, the pigtail was withdrawn, and another watchman was prepped and advanced.As the watchman came into view, i obtained a static image and assured the 'feet' of the device were within the delivery specifications.As i was advancing the watchman towards the appendage, but still well within the delivery sheath, the sheath itself appeared to 'jump forward'.Comparison imaging suggested the delivery sheath had advanced approximately 1cm beyond initial placement.With contrast injection, it was evident that the sheath was beyond the anticipated placement and indeed there was contrast within the pericardial space.With continuous transesophageal echocardiography, there was no pericardial effusion.We notified cardiothoracic surgery, and i placed a 5fr arterial line in the femoral artery.The patient demonstrated hemodynamic stability throughout.The sheath was not withdrawn from the puncture site.At this time,____ and his team performed a video assisted thoracoscopic placement of an atriclip.Please see separate dictation for details.After placement of atriclip by ____, the delivery sheath was withdrawn to the right atrium.I then withdrew the double curve into the right atrium.Transesophageal echo assured the absence of a pericardial effusion, with normal valvular architecture, and no evidence of adverse injury.Notes from the operative report: "after evaluating the situation, we did have a hemodynamically stable situation, though with a large catheter plugging the opening.The patient was prepped and draped sterilely.Time-out was taken.Left lung was isolated after switching to a bronchial blocker.A 5-mm scope and camera were inserted at the fourth intercostal space mid-axillary line.We placed a more superior 5-mm port and an inferior lateral 12-mm port.After opening the pericardium with a harmonic scalpel posterior to the phrenic nerve, we were able to visualize our situation.The 16-french catheter was indeed sticking through the atrial appendage.On closer examination this was very close to the base of this appendage.I went ahead and stuck a fourth port in place for another 5-mm instrument.Once these were in position, we did suction out the blood that was present.There was a small hemopericardium.About 75 ml total of blood was removed.We were able to see most of the appendage.There was a large chicken wing portion of this noted.We sized the base.I felt a 40-mm atriclip would be adequate to exclude the entirety of the base.This was brought in through our inferior port.Given the area of the chicken wing, as well as the area of perforation, it was difficult to initially lasso all this material within.Given the proximity close to the base of the appendage, i did not feel a separate lasso removal of the catheter and then final clipping would be the appropriate steps.We eventually were able to tease most of the chicken wing through the clip and get the clip down toward the base of the appendage.Visually it felt like we had most of this in place.I then, against my usual practice, grasped some of the base of the appendage near the perforated site to help pull more tissue and invaginate more tissue into the clip proper.With the clip held up against the left atrium and pulling gently around the base near where this perforation was located, we closed the clamp with the watchman delivery device within the clamp.At this point, i felt there would be a rim of tissue around the actual perforated hole site and likely would be a hemostatic situation.At this point, holding the base of the atrial appendage up into the clamp, we gently squeezed on the atriclip to allow it to open slightly.At this point we slowing shimmied the watchman delivery device backward.I intermittently completely closed the atriclip device to make sure we were still in good position and had a cuff of tissue around this site.We again then squeezed on the atriclip delivery device to slightly open the clip and pulled the device out completely and then clamped almost simultaneously.At this portion, our delivery device was free from its transseptal puncture.I was able to visualize the actual opening in the appendage proper.We were able to squeeze the appendage free of the remainder of the blood within.There was no active bleeding, at this time, from this perforated site and there was a good rim of tissue around the base.We visually inspected the top and bottom portion of the clip as well as visualized on tee.We had very good gross appearance.We had less than 5 mm of a residual stump of appendage remaining.We were happy with its overall placement.".

• Brand Name: WATCHMAN TRUSEAL ACCESS SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9967413
• MDR Text Key: 187898762
• Report Number: 9967413
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729965718
• UDI-Public: (01)08714729965718(17)221119(10)24799320
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 24799320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28835 DA
• Patient Weight: 79