MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0567

Device Problem Leak/Splash (1354)

Patient Problems Stroke/CVA (1770); No Consequences Or Impact To Patient (2199); Cardiogenic Shock (2262); Injury (2348)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy, the iab ruptured.The insertion was reported to be axillary, which is not the method described in the device instructions for use.There was no reported injury to the patient.

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy, the iab ruptured.The insertion was reported to be axillary, which is not the method described in the device instructions for use.Medwatch mfg report number received: mw5094864.There was a reported injury to the patient.

Manufacturer Narrative

Product evaluation: the product was returned with the membrane completely unfolded with blood on the exterior and interior of the catheter.A competitor sheath and stat-gard sleeve were also returned separate from the iab.The catheter tubing, optical fiber and inner lumen were cut at approximately 63.5cm form the iab tip.The remaining portion of the iab was not returned.The stat-gard sleeve was cut at approximately 31.5cm from the stat-gard sleeve tip.An inner lumen break within a kink was observed within the membrane at approximately 23.6cm from the iab tip.Additionally, a catheter tubing kink and an optical fiber break were also observed at approximately 30.5cm from the iab tip.An underwater leak test of the balloon and catheter tubing was performed and no leaks were detected.The technician attempted to insert a 0.025¿ laboratory guidewire through the inner lumen and was found to be occluded with blood.Unable to clear the inner lumen.The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed and allowed blood to leak into the membrane and catheter tubing.The evaluation confirmed the report problem.However, we are unable to determine when this may have occurred.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).

Manufacturer Narrative

Additional information: section b - adverse event/product problem: from: product problem, to: adverse event & product problem.Section b - outcome attributed to ae: from: [blank], to: life threatening.Section h - type of reportable event: from: malfunction, to: serious injury.Section h - patient codes: from: no consequence or impact to patient, to: injury.The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint # (b)(4).

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy, the iab ruptured.The insertion was reported to be axillary, which is not the method described in the device instructions for use.Medwatch mfg report number received: mw5094864.There was a reported injury to the patient.

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy, the iab ruptured.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The patient reportedly experienced a cerebrovascular accident (cva) and the patient went into cardiogenic shock.Medwatch mfg report number received: mw5094864.There was a reported injury to the patient.

Manufacturer Narrative

Additional information: section d: unique identifier (udi)#.From: [blank].To: (b)(4).Reference complaint#: (b)(4).

Manufacturer Narrative

Additional information: section b - describe event or problem.Updated to include: the patient reportedly experienced a cerebrovascular accident (cva) and the patient went into cardiogenic shock.Section b - other relevant history.From: [blank]; to: nonischemic cardiomyopathy admitted for acute of chronic systolic heart failure; considered a candidate for heart transplant.The product was returned with the membrane completely unfolded with blood on the exterior and interior of the catheter.A competitor sheath and stat-gard sleeve were also returned separate from the iab.The catheter tubing, optical fiber and inner lumen were cut at approximately 63.5cm form the iab tip.The remaining portion of the iab was not returned.The stat-gard sleeve was cut at approximately 31.5cm from the stat-gard sleeve tip.An inner lumen break within a kink was observed within the membrane at approximately 23.6cm from the iab tip.Additionally, a catheter tubing kink and an optical fiber break were also observed at approximately 30.5cm from the iab tip.An underwater leak test of the balloon and catheter tubing was performed and no leaks were detected.The technician attempted to insert a 0.025¿ laboratory guidewire through the inner lumen and was found to be occluded with blood.Unable to clear the inner lumen.The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed and allowed blood to leak into the membrane and catheter tubing.The evaluation confirmed the report problem.However, we are unable to determine when this may have occurred.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #: (b)(4).

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy, the iab ruptured.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The patient reportedly experienced a cerebrovascular accident (cva) and the patient went into cardiogenic shock.Medwatch mfg report number received: mw5094864.There was a reported injury to the patient.

• Brand Name: SENSATION PLUS 7.5FR. 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10195621
• MDR Text Key: 202425764
• Report Number: 2248146-2020-00305
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 06/30/2020; 07/30/2020; 08/07/2020; 08/28/2020
• Supplement Dates FDA Received: 07/21/2020; 07/31/2020; 08/17/2020; 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 40 YR
• Patient Weight: 60