MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CARDIAC UNKNOWN MATERIAL; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number CARDIAC UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call from a fellow cardiologist that the (rn) registered nurse had turned the patient in the bed and now there is blood (small amount) in the gas line tubing.The fellow notified the attending and was told it was ok to leave and the fellow was questioning this.The (css) clinical support specialist explained that the fellow is correct, pumping should stop and the iab must be immediately removed.The css and fellow discussed clotting and catheter entrapment.The fellow is going to call the css back post removal to update the css.At 2148 est- the fellow called the css back the iab was immediately removed without incident.They have decided not to reinsert at this time.There are no noted complications and the iab was kept as requested for return.(the fellow is unable to provide the css with serial numbers) the fellow stated that there was no blood noted back to the pump.The css told the fellow they should have the pump checked by biomed to be sure and the fellow understood.On (b)(6) 2016- 0945 the css spoke to the rn who is the nurse for the patient on this day.The rn stated the patient is critical but maintaining pressures with minimal dose dopamine so they have opted still to not reinsert.There are no noted complications at this time.

Manufacturer Narrative

(b)(4).No product was returned for evaluation.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.Conclusion: the reported complaint of blood in helium pathway is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.If the sample is returned at a later date, a full investigation will be completed.

Event Description

It was reported via a hot line call from a fellow cardiologist that the (rn) registered nurse had turned the patient in the bed and now there is blood (small amount) in the gas line tubing.The fellow notified the attending and was told it was ok to leave and the fellow was questioning this.The (css) clinical support specialist explained that the fellow is correct, pumping should stop and the iab must be immediately removed.The css and fellow discussed clotting and catheter entrapment.The fellow is going to call the css back post removal to update the css.At 2148 est- the fellow called the css back the iab was immediately removed without incident.They have decided not to reinsert at this time.There are no noted complications and the iab was kept as requested for return.(the fellow is unable to provide the css with serial numbers) the fellow stated that there was no blood noted back to the pump.The css told the fellow they should have the pump checked by biomed to be sure and the fellow understood.On (b)(6) 2016- 0945 the css spoke to the rn who is the nurse for the patient on this day.The rn stated the patient is critical but maintaining pressures with minimal dose dopamine so they have opted still to not reinsert.There are no noted complications at this time.

• Brand Name: CARDIAC UNKNOWN MATERIAL
• Type of Device: INTRA- AORTIC BALLOOON PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 6057784
• MDR Text Key: 58417707
• Report Number: 1219856-2016-00232
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2016

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 Catalogue Number: CARDIAC UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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